title: A French, Multicenter, Prospective, Observational, "Real Life" Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms

summary: A French, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms

lead_sponsor: Microvention-Terumo, Inc.

sponsor_collaborators:
Microvention-Terumo, Inc.
Clinact

location_facility: Hôpital d'instruction des Armées Saint-Anne


title: Evaluation of Intermittent Pneumatic Compression Associated With Elastic Stockings and Anticoagulant Prophylaxis Versus Anticoagulant Prophylaxis Alone on Venous Thromboembolism Incidence in ICU Patients Without High Risk of Bleeding

summary: This multicentre open-label randomized parallel-group trial aims to compare the association of intermittent pneumatic compression of the lower limbs + elastic stockings + anticoagulant prophylaxis to anticoagulant prophylaxis alone on the incidence of venous thromboembolism systematically evaluated at day 6, in patients hospitalized in intensive care units and without high bleeding risk.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Tyco Healthcare Group

location_country: Monaco France

location_facility:
CH de Morlaix
CH de Corbeil Essonne
CHU de Poitiers
CH Monaco
CHU de Dijon
CHU de Tours
Medical Intensive Care Unit
CHU d'Angers
CH de St Malo
HIA Clermont-Tonnerre
CH Montauban
CH de Quimper
CH d'Angoulême

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation of Intermittent Pneumatic Compression (IPC) of the Lower Limbs Associated With Elastic Stockings (ES) Compared to ES Alone on Venous Thromboembolism Incidence in Patients With High Bleeding Risk Hospitalized in Intensive Medical Care Units

summary: This multicentre open-label randomized parallel-group trial aims to evaluate the association intermittent pneumatic compression + elastick stockings versus elasting stockings alone on symptomatic or asymptomatic venous thromboembolism incidence, evaluated systematically at day 6 (+/-2days), in patients hospitalized in intensive care units and with high bleeding risk.

location_facility:
Medical Intensive Care Unit
Medical intensive care unit
HIA Clermont-Tonnerre
Intensive Care Unit


title: Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes

acronym: STOP

summary:
Ankylosing spondylitis (AS) is a frequent chronic inflammatory rheumatic disease that affects the axial skeleton, starting in the sacroiliac joints and spreading to the spine in most patients. Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary treatment for AS. Even if the use of anti-TNF agents has demonstrated good clinical efficacy in controlling inflammation, in contrast to other conditions such as rheumatoid arthritis and psoriatic arthritis, anti-TNF treatment has failed to demonstrate any benefit on the structural progression of AS, some data even suggesting that it may accelerate the formation of syndesmophytes that seems to be an independent process of TNF. Conversely, NSAIDs inhibit ossification phenomena independently of their anti-inflammatory properties, owing to a specific action on bone formation via prostaglandin inhibition.

Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF treatment, to prevent syndesmophyte formation in AS patients.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: University Hospital, Bordeaux

location_facility: service de rhumatologie - CHU de Montpellier

location_facility: service de rhumatologie - CHU de Strasbourg

location_facility: Service de rhumatologie - AP-HP - Hôpital Lariboisière

location_facility: service de rhumatologie - AP-HP - Hôpital Ambroise Paré

location_facility: service de Rhumatologie - CH Princesse Grace

location_facility: Service de Rhumatologie - CHU de Bordeaux

location_facility: service de rhumatologie - CHU de Saint-Etienne

location_facility: service de rhumatologie - AP-HP - Hôpital Henri Mondor

location_facility: service de rhumatologie - CHU de Toulouse

location_facility: service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière

location_facility: Service de rhumatologie - CHU de Besançon

location_facility: service de rhumatologie - CHU de Limoges

intervention_type: Drug

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: STOP

titre: Intérêt du maintien d'un traitement anti-inflammatoire non stéroïdien chez les patients atteints de spondylarthrite ankylosante et traités par anti-TNF pour prévenir la progression des lésions radiologiques

discipline_principale: rhumatologie

nom_porteur: SCHAEVERBEKE

prenom_porteur: Thierry


title: Safety and Efficacy of Ibritumomab Tiuxetan (Zevalin®) in Association With a Fludarabine Based Reduced Conditioning Regimen and Allogenic Stem Cell Support in Chemo-sensitive Relapsed CD20 Positive Aggressive Non-Hodgkin's Lymphoma Patients.

acronym: ZEVALLO

summary: The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced Intensity Conditioning regimen followed by allogenic stem cell support in patients with aggressive lymphomas who are responsive to a salvage chemotherapy regimen.

ReferenceType: background

ReferenceCitation: Cheson BD. The role of radioimmunotherapy with yttrium-90 ibritumomab tiuxetan in the treatment of non-Hodgkin lymphoma. BioDrugs. 2005;19(5):309-22. doi: 10.2165/00063030-200519050-00004.

ReferenceCitation: Chopra R, Goldstone AH, Pearce R, Philip T, Petersen F, Appelbaum F, De Vol E, Ernst P. Autologous versus allogeneic bone marrow transplantation for non-Hodgkin's lymphoma: a case-controlled analysis of the European Bone Marrow Transplant Group Registry data. J Clin Oncol. 1992 Nov;10(11):1690-5. doi: 10.1200/JCO.1992.10.11.1690.

ReferenceCitation: Dean RM, Fowler DH, Wilson WH, Odom J, Steinberg SM, Chow C, Kasten-Sportes C, Gress RE, Bishop MR. Efficacy of reduced-intensity allogeneic stem cell transplantation in chemotherapy-refractory non-hodgkin lymphoma. Biol Blood Marrow Transplant. 2005 Aug;11(8):593-9. doi: 10.1016/j.bbmt.2005.04.005.

ReferenceCitation: Escalon MP, Champlin RE, Saliba RM, Acholonu SA, Hosing C, Fayad L, Giralt S, Ueno NT, Maadani F, Pro B, Donato M, McLaughlin P, Khouri IF. Nonmyeloablative allogeneic hematopoietic transplantation: a promising salvage therapy for patients with non-Hodgkin's lymphoma whose disease has failed a prior autologous transplantation. J Clin Oncol. 2004 Jun 15;22(12):2419-23. doi: 10.1200/JCO.2004.09.092.

ReferenceCitation: Fietz T, Uharek L, Gentilini C, Muessig A, Rieger K, Marinets O, Sandrock D, Munz DL, Glass B, Thiel E, Blau IW. Allogeneic hematopoietic cell transplantation following conditioning with 90Y-ibritumomab-tiuxetan. Leuk Lymphoma. 2006 Jan;47(1):59-63. doi: 10.1080/10428190500260478.

ReferenceCitation: Frater JL, Hsi ED. Properties of the mantle cell and mantle cell lymphoma. Curr Opin Hematol. 2002 Jan;9(1):56-62. doi: 10.1097/00062752-200201000-00010.

ReferenceCitation: Freytes CO, Loberiza FR, Rizzo JD, Bashey A, Bredeson CN, Cairo MS, Gale RP, Horowitz MM, Klumpp TR, Martino R, McCarthy PL, Molina A, Pavlovsky S, Pecora AL, Serna DS, Tsai T, Zhang MJ, Vose JM, Lazarus HM, van Besien K; Lymphoma Working Committee of the International Bone Marrow Transplant Registry. Myeloablative allogeneic hematopoietic stem cell transplantation in patients who experience relapse after autologous stem cell transplantation for lymphoma: a report of the International Bone Marrow Transplant Registry. Blood. 2004 Dec 1;104(12):3797-803. doi: 10.1182/blood-2004-01-0231. Epub 2004 Jul 27.

ReferenceCitation: Gianni AM, Cortelazzo S, Magni M, Martelli M; Michelangelo Cooperative. Rituximab: enhancing stem cell transplantation in mantle cell lymphoma. Bone Marrow Transplant. 2002 Feb;29 Suppl 1:S10-3. doi: 10.1038/sj.bmt.1703296.

ReferenceCitation: Gopal AK, Pagel JM, Rajendran JG, Maloney DG, Appelbaum FR, Sorror ML, Sandmaier BM, Storb R, Press OW. Improving the efficacy of reduced intensity allogeneic transplantation for lymphoma using radioimmunotherapy. Biol Blood Marrow Transplant. 2006 Jul;12(7):697-702. doi: 10.1016/j.bbmt.2006.03.014.

ReferenceCitation: Grigg A, Ritchie D. Graft-versus-lymphoma effects: clinical review, policy proposals, and immunobiology. Biol Blood Marrow Transplant. 2004 Sep;10(9):579-90. doi: 10.1016/j.bbmt.2004.05.008.

ReferenceCitation: Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.

ReferenceCitation: Johnson TA, Press OW. Synergistic cytotoxicity of iodine-131-anti-CD20 monoclonal antibodies and chemotherapy for treatment of B-cell lymphomas. Int J Cancer. 2000 Jan 1;85(1):104-12. doi: 10.1002/(sici)1097-0215(20000101)85:13.0.co;2-g.

ReferenceCitation: Jones RJ, Ambinder RF, Piantadosi S, Santos GW. Evidence of a graft-versus-lymphoma effect associated with allogeneic bone marrow transplantation. Blood. 1991 Feb 1;77(3):649-53.

ReferenceCitation: Khouri IF, Keating M, Korbling M, Przepiorka D, Anderlini P, O'Brien S, Giralt S, Ippoliti C, von Wolff B, Gajewski J, Donato M, Claxton D, Ueno N, Andersson B, Gee A, Champlin R. Transplant-lite: induction of graft-versus-malignancy using fludarabine-based nonablative chemotherapy and allogeneic blood progenitor-cell transplantation as treatment for lymphoid malignancies. J Clin Oncol. 1998 Aug;16(8):2817-24. doi: 10.1200/JCO.1998.16.8.2817.

ReferenceCitation: Khouri IF, Lee MS, Romaguera J, Mirza N, Kantarjian H, Korbling M, Albitar M, Giralt S, Samuels B, Anderlini P, Rodriguez J, von Wolff B, Gajewski J, Cabanillas F, Champlin R. Allogeneic hematopoietic transplantation for mantle-cell lymphoma: molecular remissions and evidence of graft-versus-malignancy. Ann Oncol. 1999 Nov;10(11):1293-9. doi: 10.1023/a:1008380527502.

ReferenceCitation: Khouri IF, Lee MS, Saliba RM, Jun G, Fayad L, Younes A, Pro B, Acholonu S, McLaughlin P, Katz RL, Champlin RE. Nonablative allogeneic stem-cell transplantation for advanced/recurrent mantle-cell lymphoma. J Clin Oncol. 2003 Dec 1;21(23):4407-12. doi: 10.1200/JCO.2003.05.501.

ReferenceCitation: Maris MB, Sandmaier BM, Storer BE, Chauncey T, Stuart MJ, Maziarz RT, Agura E, Langston AA, Pulsipher M, Storb R, Maloney DG. Allogeneic hematopoietic cell transplantation after fludarabine and 2 Gy total body irradiation for relapsed and refractory mantle cell lymphoma. Blood. 2004 Dec 1;104(12):3535-42. doi: 10.1182/blood-2004-06-2275. Epub 2004 Aug 10.

ReferenceCitation: Milpied N, Deconinck E, Gaillard F, Delwail V, Foussard C, Berthou C, Gressin R, Lucas V, Colombat P, Harousseau JL; Groupe Ouest-Est des Leucemies et des Autres Maladies du Sang. Initial treatment of aggressive lymphoma with high-dose chemotherapy and autologous stem-cell support. N Engl J Med. 2004 Mar 25;350(13):1287-95. doi: 10.1056/NEJMoa031770.

ReferenceCitation: Morris E, Thomson K, Craddock C, Mahendra P, Milligan D, Cook G, Smith GM, Parker A, Schey S, Chopra R, Hatton C, Tighe J, Hunter A, Peggs K, Linch D, Goldstone A, Mackinnon S. Outcomes after alemtuzumab-containing reduced-intensity allogeneic transplantation regimen for relapsed and refractory non-Hodgkin lymphoma. Blood. 2004 Dec 15;104(13):3865-71. doi: 10.1182/blood-2004-03-1105. Epub 2004 Aug 10.

ReferenceCitation: Nademanee A, Forman SJ. Role of hematopoietic stem cell transplantation for advanced-stage diffuse large cell B-cell lymphoma-B. Semin Hematol. 2006 Oct;43(4):240-50. doi: 10.1053/j.seminhematol.2006.07.006.

ReferenceCitation: Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, Sonneveld P, Gisselbrecht C, Cahn JY, Harousseau JL, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med. 1995 Dec 7;333(23):1540-5. doi: 10.1056/NEJM199512073332305.

ReferenceCitation: Ratanatharathorn V, Uberti J, Karanes C, Abella E, Lum LG, Momin F, Cummings G, Sensenbrenner LL. Prospective comparative trial of autologous versus allogeneic bone marrow transplantation in patients with non-Hodgkin's lymphoma. Blood. 1994 Aug 15;84(4):1050-5.

ReferenceCitation: Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205. doi: 10.1056/NEJMoa042040.

ReferenceCitation: Rodriguez R, Nademanee A, Ruel N, Smith E, Krishnan A, Popplewell L, Zain J, Patane K, Kogut N, Nakamura R, Sarkodee-Adoo C, Forman SJ. Comparison of reduced-intensity and conventional myeloablative regimens for allogeneic transplantation in non-Hodgkin's lymphoma. Biol Blood Marrow Transplant. 2006 Dec;12(12):1326-34. doi: 10.1016/j.bbmt.2006.08.035.

ReferenceCitation: Schimmer AD, Jamal S, Messner H, Keating A, Meharchand J, Huebsch L, Walker I, Benger A, Gluck S, Smith A. Allogeneic or autologous bone marrow transplantation (BMT) for non-Hodgkin's lymphoma (NHL): results of a provincial strategy. Ontario BMT Network, Canada. Bone Marrow Transplant. 2000 Oct;26(8):859-64. doi: 10.1038/sj.bmt.1702625.

ReferenceCitation: Shenkier TN, Voss N, Fairey R, Gascoyne RD, Hoskins P, Klasa R, Klimo P, O'Reilly SE, Sutcliffe S, Connors JM. Brief chemotherapy and involved-region irradiation for limited-stage diffuse large-cell lymphoma: an 18-year experience from the British Columbia Cancer Agency. J Clin Oncol. 2002 Jan 1;20(1):197-204. doi: 10.1200/JCO.2002.20.1.197.

ReferenceCitation: Slavin S, Nagler A, Naparstek E, Kapelushnik Y, Aker M, Cividalli G, Varadi G, Kirschbaum M, Ackerstein A, Samuel S, Amar A, Brautbar C, Ben-Tal O, Eldor A, Or R. Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematologic diseases. Blood. 1998 Feb 1;91(3):756-63.

ReferenceCitation: Vandenberghe E, Ruiz de Elvira C, Loberiza FR, Conde E, Lopez-Guillermo A, Gisselbrecht C, Guilhot F, Vose JM, van Biesen K, Rizzo JD, Weisenburger DD, Isaacson P, Horowitz MM, Goldstone AH, Lazarus HM, Schmitz N. Outcome of autologous transplantation for mantle cell lymphoma: a study by the European Blood and Bone Marrow Transplant and Autologous Blood and Marrow Transplant Registries. Br J Haematol. 2003 Mar;120(5):793-800. doi: 10.1046/j.1365-2141.2003.04140.x.

ReferenceCitation: Winter JN. Combining yttrium 90-labeled ibritumomab tiuxetan with high-dose chemotherapy and stem cell support in patients with relapsed non-Hodgkin's lymphoma. Clin Lymphoma. 2004 Oct;5 Suppl 1:S22-6. doi: 10.3816/clm.2004.s.005.

ReferenceType: derived

ReferenceCitation: Bouabdallah K, Furst S, Asselineau J, Chevalier P, Tournilhac O, Ceballos P, Vigouroux S, Tabrizi R, Doussau A, Bouabdallah R, Mohty M, Le Gouill S, Blaise D, Milpied N. 90Y-ibritumomab tiuxetan, fludarabine, busulfan and antithymocyte globulin reduced-intensity allogeneic transplant conditioning for patients with advanced and high-risk B-cell lymphomas. Ann Oncol. 2015 Jan;26(1):193-198. doi: 10.1093/annonc/mdu503. Epub 2014 Oct 30.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

sponsor_collaborators:
University Hospital, Bordeaux
Bayer

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan

location_facility: Pôle hématologie et immunologie clinique - Hôpital Saint-Louis

location_facility: Département d'hématologie et d'Oncologie - CHRU Hautepierre

location_facility: Service d'Oncologie Hématologie, Institut Paoli Calmettes - 232 Bd Ste Marguerite

location_facility: Hématologie et Oncologie médicale - CHU Lapeyronie

location_facility: Service d'Hématologie, Hôpital Hôtel Dieu, CHU Nantes - 1 Place Alexis Ricordeau

location_facility: Service d'Hématologie Adultes - Hôpital Necker-Enfants Malade

location_facility: Service d'hématologie - CHU Hôtel Dieu Clermont-Ferrand

location_facility: Service d'hématologie clinique - Hôpital l'Archet 1

location_facility: Service de médecine nucléaire - Centre de Lutte contre le Cancer de la Région Auvergne Jean Perrin


title: Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®) (2mg) Over a 12-week Period for Patients Suffering From Neovascular Age-related Macular Degeneration (AMD) French SD OCT in wAMD

acronym: START

summary: Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Therefore it might be not necessary to consistently perform each of the three monthly consecutive intravitreal injections of the so-called loading phase.

ReferenceCitation: Patel KH, Chow CC, Rathod R, Mieler WF, Lim JI, Ulanski LJ 2nd, Leiderman YI, Arun V, Chau FY. Rapid response of retinal pigment epithelial detachments to intravitreal aflibercept in neovascular age-related macular degeneration refractory to bevacizumab and ranibizumab. Eye (Lond). 2013 May;27(5):663-7; quiz 668. doi: 10.1038/eye.2013.31. Epub 2013 Apr 5.

ReferenceCitation: Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, Mones J, Buggage R, Schaefer C, Knight T, Goss TF. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study. Pharmacoeconomics. 2008;26(1):57-73. doi: 10.2165/00019053-200826010-00006.

ReferenceCitation: Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

ReferenceCitation: Cohen SY, Souied EH, Weber M, Dupeyron G, de Pouvourville G, Lievre M, Ponthieux A. Patient characteristics and treatment of neovascular age-related macular degeneration in France: the LUEUR1 observational study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):521-7. doi: 10.1007/s00417-010-1553-0. Epub 2010 Nov 6.

ReferenceCitation: Heier JS, Boyer D, Nguyen QD, Marcus D, Roth DB, Yancopoulos G, Stahl N, Ingerman A, Vitti R, Berliner AJ, Yang K, Brown DM; CLEAR-IT 2 Investigators. The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology. 2011 Jun;118(6):1098-106. doi: 10.1016/j.ophtha.2011.03.020. Erratum In: Ophthalmology. 2011 Sep;118(9):1700.

ReferenceCitation: Korobelnik JF, Souied EH, Oubraham H, Razavi S, Mauget-Faysse M, Savel H, Chene G, Wolf S. ASSESSMENT OF EARLY CHANGES IN SPECTRAL DOMAIN-OPTICAL COHERENCE TOMOGRAPHY AFTER INITIATION OF TREATMENT WITH INTRAVITREAL AFLIBERCEPT (EYLEA) OVER A 12-WEEK PERIOD FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Multicenter French Study (START). Retina. 2021 Mar 1;41(3):588-594. doi: 10.1097/IAE.0000000000002910.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

location_facility: Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun

location_facility: Service d'Ophtalmologie Hôpital de la croix rousse

location_facility: Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908

location_facility: Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle

location_facility: Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré

location_facility: Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard

location_facility: Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau

location_facility: Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin

location_facility: Centre Ophtalmologie Transparence 30 Boulevard Heurteloup

location_facility: Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve

intervention_type: Procedure


title: Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy

summary:
Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. The rational is the fact that 15% of patients have sterilized tumours after radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm) received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between local and rectal excision. The main findings were: the rate of complete pathologic response was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes.

The objective of the new trial is to increase the proportion of patients treated with organ preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has been shown to enhance the response rate. In patients with colorectal metastases, response rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also increases response and chance of R0 resection rates in initially unresectable colorectal metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect to increase chance of organ preservation rate, as compared to radiochemotherapy alone.

primary_purpose: Supportive Care

ipd_sharing: No

location_facility: Service de Chirurgie Digestive, CHU de la Timone - Marseille

location_facility: Service de Chirurgie Digestives, Hôpital Européen de Marseille

location_facility: Service de Chirurgie Digestive, Hôpital Pontchaillou - CHU Rennes

location_facility: Service de Chirurgie Digestive, Centre Georges François Leclerc - Dijon

location_facility: Service de Chirurgie Digestive, Hôpital Saint-Antoine - APHP

location_facility: Service de Chirurgie Digestive,Institut de Cancérologie de Lorraine

location_facility: Service de Chirurgie Digestive, Institut Bergonié

location_facility: Service de Chirurgie Digestive, Hôpital Saint-André - CHU de Bordeaux

location_facility: Service de Chirurgie Digestive, CHU de Besançon

location_facility: Département de chirurgie digestive, Institut Gustave Roussy

location_facility: Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble

location_facility: Service de Chirurgie Digestive, Hôpital Saint-Louis - APHP Paris

location_facility: Service de Chirurgie Digestive, Institut Paoli Calmette - Marseille

location_facility: Service de Chirurgie Digestive, Hôpital Charles Nicolle - CHU de Rouen

location_facility: Service de Chirurgie Digestive, Hôpital Beaujon - APHP

location_facility: Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre - APHP

location_facility: Service de Chirurgie Digestive, Hôtel Dieu - CHU de Nantes

location_facility: Service de Chirurgie Digestive, Hôpital Lyon Sud - CHU Lyon

location_facility: Service de Chirurgie Digestive, Hôpital les Diaconnesses

location_facility: Service de Chirurgie Digestive, CHU Amiens Picardie

location_facility: Service de chirurgie digestive, CHRU de Nancy -Hôpital de Brabois

location_facility: Service de Chirurgie Digestive, CHU Estaing - CHRU Clermont Ferrand

location_facility: Service de Chirurgie Digestive, Institut du Cancer de Montpellier

location_facility: Service de Chirurgie Digestive, Centre Léon Bérard - Lyon

location_facility: Service de Chirurgie Digestive, Centre Oscar Lambret - Lille

location_facility: Service d'Oncologie et Radiothérapie, Centre Azuréen de Cancérologie

location_facility: Service de Chirurgie Digestive, Hôpital Purpan - CHU de Toulouse

location_facility: Service de Chirurgie Digestive, CHU Carémeau - Nîmes


title: Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib

acronym: STIM 2

summary:
Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials.

Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.

enrollment_type: Anticipated

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: CH Régional de l'ILE DE LA REUNION/ Groupe Hospitalier Sud

location_facility: Lille University hospital - Hôpital Claude Huriez

location_facility: University Hospital Bordeaux, Hôpital du Haut Lévêque

location_facility: University Hospital Poitiers - Hôpital Jean Bernard


title: Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old

acronym: LAM-SA 2007

summary: A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

ReferenceCitation: Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE, Petersdorf SH. Age and acute myeloid leukemia. Blood. 2006 May 1;107(9):3481-5. doi: 10.1182/blood-2005-09-3724. Epub 2006 Feb 2.

ReferenceCitation: Sekeres MA, Stone R. Older adults with acute myeloid leukemia. Curr Oncol Rep. 2002 Sep;4(5):403-9. doi: 10.1007/s11912-002-0034-y.

ReferenceCitation: Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E 3rd. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994 Oct 6;331(14):896-903. doi: 10.1056/NEJM199410063311402.

ReferenceCitation: Stone RM, Berg DT, George SL, Dodge RK, Paciucci PA, Schulman P, Lee EJ, Moore JO, Powell BL, Schiffer CA. Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. Cancer and Leukemia Group B. N Engl J Med. 1995 Jun 22;332(25):1671-7. doi: 10.1056/NEJM199506223322503.

ReferenceCitation: Witz F, Sadoun A, Perrin MC, Berthou C, Briere J, Cahn JY, Lioure B, Witz B, Francois S, Desablens B, Pignon B, Le Prise PY, Audhuy B, Caillot D, Casassus P, Delain M, Christian B, Tellier Z, Polin V, Hurteloup P, Harousseau JL. A placebo-controlled study of recombinant human granulocyte-macrophage colony-stimulating factor administered during and after induction treatment for de novo acute myelogenous leukemia in elderly patients. Groupe Ouest Est Leucemies Aigues Myeloblastiques (GOELAM). Blood. 1998 Apr 15;91(8):2722-30.

ReferenceCitation: Pigneux A, Perreau V, Jourdan E, Vey N, Dastugue N, Huguet F, Sotto JJ, Salmi LR, Ifrah N, Reiffers J. Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results. Haematologica. 2007 Oct;92(10):1327-34. doi: 10.3324/haematol.11068.

ReferenceCitation: Takagi K. [Neurophysiological and clinical aspects of autonomic centers: introduction]. Nihon Seirigaku Zasshi. 1972 May;34(5):257-61. No abstract available. Japanese.

ReferenceCitation: Gardin C, Turlure P, Fagot T, Thomas X, Terre C, Contentin N, Raffoux E, de Botton S, Pautas C, Reman O, Bourhis JH, Fenaux P, Castaigne S, Michallet M, Preudhomme C, de Revel T, Bordessoule D, Dombret H. Postremission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy: results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial. Blood. 2007 Jun 15;109(12):5129-35. doi: 10.1182/blood-2007-02-069666. Epub 2007 Mar 6.

ReferenceCitation: Hegenbart U, Niederwieser D, Sandmaier BM, Maris MB, Shizuru JA, Greinix H, Cordonnier C, Rio B, Gratwohl A, Lange T, Al-Ali H, Storer B, Maloney D, McSweeney P, Chauncey T, Agura E, Bruno B, Maziarz RT, Petersen F, Storb R. Treatment for acute myelogenous leukemia by low-dose, total-body, irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors. J Clin Oncol. 2006 Jan 20;24(3):444-53. doi: 10.1200/JCO.2005.03.1765. Epub 2005 Dec 12.

ReferenceCitation: Largeaud L, Cornillet-Lefebvre P, Hamel JF, Dumas PY, Prade N, Dufrechou S, Plenecassagnes J, Luquet I, Blanchet O, Banos A, Bene MC, Bernard M, Bertoli S, Bonmati C, Fornecker LM, Guieze R, Haddaoui L, Hunault M, Ianotto JC, Jourdan E, Ojeda M, Peterlin P, Vey N, Zerazhi H, Yosr H, Mineur A, Cahn JY, Ifrah N, Recher C, Pigneux A, Delabesse E; French Innovative Leukemia Organization (FILO). Lomustine is beneficial to older AML with ELN2017 adverse risk profile and intermediate karyotype: a FILO study. Leukemia. 2021 May;35(5):1291-1300. doi: 10.1038/s41375-020-01031-1. Epub 2020 Sep 18.

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_normalized: HAL

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

location_facility: Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier

location_facility: Service Hématologie Clinique, Hôpital Robert Debre

location_facility: Service Hématologie Clinique, Hôpital Pontchaillou

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque

location_facility: Service Hématologie, Hôpital Augustin Morvan

location_facility: Service des maladies du sang, Centre Hospitalier Universitaire d'Angers

location_facility: Service Hématologie, Hôpital Dr Duchenne

location_facility: Service Hématologie Oncologie, CHR Metz-Thionville

location_facility: Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens

location_facility: Service Hématologie Clinique, Hôpital Archet 1

location_facility: Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon

location_facility: Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre

location_facility: Service Hématologie Clinique, CHU Dijon Hôpital des enfants

location_facility: Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse

location_facility: Service Hématologie, Centre Hospitalier Annecy

location_facility: Service Hématologie Clinique, Hôpital Bretonneau

location_facility: Service Onco-Hématologie 3, Institut Paoli Calmettes

location_facility: Unité Hématologie, Centre Hospitalier Blois

location_facility: Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble

location_facility: Service Hématologie Clinique, CHU -Hôtel Dieu

location_facility: Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand

location_facility: Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar

location_facility: Service Oncologie Médicale, Hôpital de la Source

location_facility: Service Hématologie - Médecine Interne, Hôpitaux de Brabois

location_facility: Service d'Hématologie, Institut de Cancérologhie de la Loire

location_facility: Service Médecine B - Unité Onco-hématologique, CHU Caremeau

location_facility: Service Hématologie, Centre Hospitalier de la Côte Basque


title: Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)

acronym: STIM

summary: The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.

design_allocation: Non-Randomized

ReferenceCitation: Rea D, Henry G, Khaznadar Z, Etienne G, Guilhot F, Nicolini F, Guilhot J, Rousselot P, Huguet F, Legros L, Gardembas M, Dubruille V, Guerci-Bresler A, Charbonnier A, Maloisel F, Ianotto JC, Villemagne B, Mahon FX, Moins-Teisserenc H, Dulphy N, Toubert A. Natural killer-cell counts are associated with molecular relapse-free survival after imatinib discontinuation in chronic myeloid leukemia: the IMMUNOSTIM study. Haematologica. 2017 Aug;102(8):1368-1377. doi: 10.3324/haematol.2017.165001. Epub 2017 May 18.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Lille

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.

location_facility: Centre hospitalier-service de médecine interne Onco-Hématologique

location_facility: University Hospital Bordeaux, Groupe Hospitalier Pellegrin

location_facility: University Hospital Strasbourg, Hôpital Civil

intervention_type: Behavioral


title: Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)

acronym: PHARMA-A

summary: The Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.

ReferenceCitation: Bui S, Facchin A, Ha P, Bouchet S, Leroux S, Nacka F, Fayon M, Jacqz-Aigrain E. Population pharmacokinetics of ceftazidime in critically ill children: impact of cystic fibrosis. J Antimicrob Chemother. 2020 Aug 1;75(8):2232-2239. doi: 10.1093/jac/dkaa170.

publisher_dissemination: Oxford University Press

location_facility:
APHP - Hôpital NEcker
CHU Montpellier
CHU tours
CHU Toulouse
CHU de Dijon
AP-HM, Hôpital La Timone
CHU de Bordeaux, Hôpital Pellegrin
CHRU Lille
Hospices Civils de Lyon
CHU de Grenoble
CHU Poitiers
CHU Rouen
CHU Clermont Ferrand
AP-HP - Hôpital Robert Debré


title: Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study

acronym: DOCTORS

summary:
Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting. - To date, no study has evaluated whether optical coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI) and stenting.

The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided angioplasty would provide useful clinical information beyond that obtained by angiography, and whether this information would subsequently modify physician behavior and treatment choices. In particular, we will evaluate the impact of changes in procedural strategy resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute coronary syndromes.

ReferenceCitation: Meneveau N, Ecarnot F, Souteyrand G, Motreff P, Caussin C, Van Belle E, Ohlmann P, Morel O, Grentzinger A, Angioi M, Chopard R, Schiele F. Does optical coherence tomography optimize results of stenting? Rationale and study design. Am Heart J. 2014 Aug;168(2):175-81.e1-2. doi: 10.1016/j.ahj.2014.05.007. Epub 2014 May 24.

ReferenceType: result

ReferenceCitation: Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

ReferenceCitation: Meneveau N, Ecarnot F. Response by Meneveau and Ecarnot to Letter Regarding Article, "Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients With Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting)". Circulation. 2017 Feb 28;135(9):e142-e143. doi: 10.1161/CIRCULATIONAHA.116.026277. No abstract available.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire Régional

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

acronyme: DOCTORS

titre: La Tomographie par Cohérence Optique améliore-t-elle le résultat de la mise en place d'une prothèse endocoronaire?

discipline_principale: cardiologie

nom_porteur: MENEVEAU

prenom_porteur: Nicolas


type: Other Identifier

title: On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men

acronym: IPERGAY

summary: This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel groups is designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada versus placebo, associated with overall prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed recent studies have reported a higher incidence of new HIV infection in MSM as compared to the general population, new approaches to the prevention of HIV infection are, therefore, necessary in order to consider the limits of current strategies.

primary_purpose: Prevention

ReferenceCitation: Antoni G, Tremblay C, Delaugerre C, Charreau I, Cua E, Rojas Castro D, Raffi F, Chas J, Huleux T, Spire B, Capitant C, Cotte L, Meyer L, Molina JM; ANRS IPERGAY study group. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV. 2020 Feb;7(2):e113-e120. doi: 10.1016/S2352-3018(19)30341-8. Epub 2019 Nov 26.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

ReferenceCitation: Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bebear C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Dore V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.

ReferenceCitation: Molina JM, Charreau I, Spire B, Cotte L, Chas J, Capitant C, Tremblay C, Rojas-Castro D, Cua E, Pasquet A, Bernaud C, Pintado C, Delaugerre C, Sagaon-Teyssier L, Mestre SL, Chidiac C, Pialoux G, Ponscarme D, Fonsart J, Thompson D, Wainberg MA, Dore V, Meyer L; ANRS IPERGAY Study Group. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 2017 Sep;4(9):e402-e410. doi: 10.1016/S2352-3018(17)30089-9. Epub 2017 Jul 23.

ReferenceCitation: Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Preau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Dore V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country: Canada France

location_facility:
Hôpital Saint-Louis
Hôpital Tenon
Hôpital Gustave Dron
Hôpital de La Croix Rousse
CHU Hôtel Dieu
CHUM - Hôpital Hôtel Dieu
Hôpital de l'Archet


title: A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)

acronym: PHOS-ISTOS

summary: This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp

ReferenceCitation: Vignion-Dewalle AS, Abi Rached H, Thecua E, Lecomte F, Deleporte P, Behal H, Hommel T, Duhamel A, Szeimies RM, Mortier L, Mordon S. A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study). JMIR Res Protoc. 2019 Apr 26;8(4):e12990. doi: 10.2196/12990.

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

publisher_dissemination: JMIR Publications

lead_sponsor: University Hospital, Lille

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_country: Germany France

location_facility:
CHRU, Hôpital Claude Huriez
Klinikum Vest Gmbh


acronym: DOSINDYGO

summary: The phase II study evaluate a light dose escalation in a classical intraoperative PDT regimen mediated by 5-ALA-PpIX, in glioblastoma patients with access to full surgical removal of the contrast enhancement. This treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the Stupp protocol.

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Hôpital Erasme, Clinique Universitaire de Bruxelles

status: Recruiting

title: A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma

type: EudraCT Number

source: euctr

location_country: Belgium France


title: LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable Hepacellular Carcinoma

summary: The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: de Baere T, Guiu B, Ronot M, Chevallier P, Sergent G, Tancredi I, Tselikas L, Dioguardi Burgio M, Raynaud L, Deschamps F, Verset G. Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry. Cancers (Basel). 2020 Nov 17;12(11):3405. doi: 10.3390/cancers12113405.

repository_institution: MDPI AG - MDPI

repositories:
HAL
PubMed Central
mdpi.com

repositories_concat: HAL;PubMed Central;mdpi.com

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

publisher_dissemination: MDPI

ipd_sharing: Undecided

lead_sponsor: Terumo Europe N.V.

location_facility:
Hôpital Universitaire Saint-Eloi
Cliniques Universitaires Saint Luc
CHRU Lille
Hôpital Beaujon
Institut Gustave Roussy
Hôpital Erasme
Hôpital L'Archet II

lead_sponsor_type: industriel


lead_sponsor: AB Science

summary: Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe COVID-19.

ReferenceCitation: Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

repositories_concat: PubMed Central

publisher_dissemination: American Chemical Society

location_facility: Le Tripode, Groupe hospitalier Pellegrin CHU de Bordeaux

location_facility: CHU Clermont-Ferrand: Site Gabriel-Montpied

title: Randomized, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Masitinib Combined With Isoquercetin, and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19


title: BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication

acronym: BioCONTINUE

summary:
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question.

80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device.

So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.

lead_sponsor: Biotronik SE & Co. KG

location_country: Germany France Italy Portugal Hungary Belgium Spain Israel

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Cliniques du Tonkin, de la Sauvegarde et Protestante

location_facility: Hospital Universitario Marques de Valdecilla


title: Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer

summary:
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity.

Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen.

Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen

status: Unknown status

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

status_simplified: Unknown


title: Assessment of the Numen Stent With Evaluation in a Randomized Study

acronym: ANSWERS

summary: The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the VISION/MINIVISION coronary stent

lead_sponsor: International Biomedical Systems S.p.A.

location_facility:
Clinique Vert Coteau
Clinique Alleray-Labrouste
Centre Hospitalier Privé Beauregard
Clinique Saint Gatien
Clinique Turin
Clinique Valmente
CMC De Parly II
CHU Cote de Nacre


title: Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

acronym: TRAUMAX

summary: The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX

lead_sponsor: Integra LifeSciences Services

location_facility: Hôpital d'Instruction des Armées R. Picqué

location_facility: Nouvelle Clinique de l'Union et du Vaurais

location_facility: Centre Hospitalier Départemental de Vendée


title: Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.

summary: The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).

lead_sponsor: Terumo BCTbio

location_facility: Centre Hospitalier Universitaire Jean Minjoz

location_facility: Centre Hospitalier Univesrsitaire A Michallon

location_facility: Centre Hospitalier Régional Universitaire Hautepierre

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire Hôtel Dieu


title: During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease

acronym: AIRVO-PHYSIO

summary:
Chronic obstructive pulmonary disease is a major cause of disability and mortality worldwide. This disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation teaches chronic obstructive pulmonary disease patients to cope effectively with the systemic effects of the disease and improves exercise capacity, dyspnea and quality of life in patients with chronic obstructive pulmonary disease. However, the best training modality remains unknown. Physiological studies highlight the benefit of high intensity endurance training. However, many patients do not tolerate such a training due to ventilatory limitation and dyspnea. Therefore, a strategy to reduce dyspnea would allow a greater physiological muscle solicitation and improvement. Thus, many studies focus on means to increase exercise tolerance in patients with chronic obstructive pulmonary disease.

Nasal high flow delivers heated and humidified high flow air (up to 60 L/min) through nasal cannula providing physiological benefits such as positive airway pressure and carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.

More recently, nasal-high flow has been shown to improve endurance exercise capacity in patients with chronic obstructive pulmonary disease. However, the underlying physiological mechanisms have not been yet elucidated but may help to optimise the utilization of the device.

Therefore, the primary objective of this study is to assess the respiratory physiological effects nasal high-flow during-exercise in stable patients with chronic obstructive pulmonary disease.

Secondary objectives are to assess the effects nasal high-flow during-exercise on endurance capacity, respiratory drive, dynamic hyperinflation, cardiorespiratory pattern and muscular metabolism.

lead_sponsor: ADIR Association


title: A Phase II Multicenter, Open-Label, Clinical And Pharmacokinetic Study of Aplidin® As A 1-Hour Weekly IV Infusion, in Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

summary: This is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.

ReferenceCitation: Ribrag V, Caballero D, Ferme C, Zucca E, Arranz R, Briones J, Gisselbrecht C, Salles G, Gianni AM, Gomez H, Kahatt C, Corrado C, Szyldergemajn S, Extremera S, de Miguel B, Cullell-Young M, Cavalli F. Multicenter phase II study of plitidepsin in patients with relapsed/refractory non-Hodgkin's lymphoma. Haematologica. 2013 Mar;98(3):357-63. doi: 10.3324/haematol.2012.069757. Epub 2012 Oct 12.

lead_sponsor: PharmaMar

location_country:
Italy
Switzerland
Spain
Peru
Puerto Rico
France

location_facility: Istituto di ematologia e oncologia medica "L. e. A. Seragnoli"

location_facility: Hospital Español Auxilio Mutuo de Puerto Rico Inc.

location_facility: Instituto Nacional de Enfermedades Neoplásicas (INEN)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni


title: Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease - A Randomized Controlled Study

acronym: PPR-NHF

summary:
Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting.

Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.

More recently, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD.

Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.

status: Terminated


title: Early Immunological, Metagenomic, Metabolic and Environmental Factors in the Progression to Type 1 Diabetes: the TRAKR Cohort

acronym: TRAKR

summary: The purpose of this study is to determine whether early immunological markers (activation of autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in children born from type 1 diabetic parents.

primary_purpose: Screening

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Institut National de la Santé et de la Recherche Médicale (INSERM) U1016 - Institut Cochin, Immunology of Diabetes Team, Paris, France

collaborators: INSERM U1153, Epidemiology Research Unit on Perinatal Health and Women and Children Health, Port-Royal Hospital, Paris, France

collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

intervention_type: Other


acronym: MS-SPI

lead_sponsor: MedDay Pharmaceuticals SA

summary: The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.

location_facility: Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye

title: Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study


title: A Randomized Phase II Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

summary: A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.

location_facility: Hopital du Kremlin Bicêtre Service de médecine interne

location_facility: Service des Maladies Infectieuses et Tropicales, Hopital Tenon

location_facility: CIC de Vaccinologie Cochin Pasteur, hôpital Cochin

location_facility: Hôpital Gustave Dron, Service Maladies Infectieuses

intervention_type: Biological


title: A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence

summary: The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.

lead_sponsor: Coloplast A/S

location_country: Germany Italy Belgium Spain France

location_facility: Clinique Mutualiste de la Porte de l'Orient


title: Recombinant Human Activated Factor VII as Salvage Therapy in Women With Severe Postpartum Hemorrhage

summary: The aim of this clinical research project is to evaluate the use of the recombinant human activated factor VII (rhFVIIa), given as a salvage therapy, in women with a dramatic postpartum hemorrhage still ongoing after all the currently available medical and surgical treatments. We are going to compare its early use, before elective surgery or arterial embolization, to its late use, after embolization or surgery, before salvage hysterectomy.

ReferenceCitation: Lavigne-Lissalde G, Aya AG, Mercier FJ, Roger-Christoph S, Chauleur C, Morau E, Ducloy-Bouthors AS, Mignon A, Raucoules M, Bongain A, Boehlen F, de Moerloose P, Bouvet S, Fabbro-Peray P, Gris JC. Recombinant human FVIIa for reducing the need for invasive second-line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial. J Thromb Haemost. 2015 Apr;13(4):520-9. doi: 10.1111/jth.12844. Epub 2015 Mar 11.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

collaborators: Centre Hospitalier Universitaire de Nice

location_country: Switzerland France

location_facility: Laboratoire d'hématologie, Groupe Hospitalo-Universitaire Caremeau


summary: The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.

ReferenceCitation: Arock M. A new therapeutic advance for symptomatic systemic mastocytosis? Lancet. 2017 Feb 11;389(10069):576-578. doi: 10.1016/S0140-6736(16)31655-5. Epub 2017 Jan 7. No abstract available.

ReferenceCitation: Lortholary O, Chandesris MO, Bulai Livideanu C, Paul C, Guillet G, Jassem E, Niedoszytko M, Barete S, Verstovsek S, Grattan C, Damaj G, Canioni D, Fraitag S, Lhermitte L, Georgin Lavialle S, Frenzel L, Afrin LB, Hanssens K, Agopian J, Gaillard R, Kinet JP, Auclair C, Mansfield C, Moussy A, Dubreuil P, Hermine O. Masitinib for treatment of severely symptomatic indolent systemic mastocytosis: a randomised, placebo-controlled, phase 3 study. Lancet. 2017 Feb 11;389(10069):612-620. doi: 10.1016/S0140-6736(16)31403-9. Epub 2017 Jan 7.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - INERIS

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repository_institution: OSF Preprints - OSF Preprints

repositories:
HAL
PubMed Central
share.osf.io

repositories_concat: HAL;PubMed Central;share.osf.io

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

location_facility: UC Davis Health System , Department of Dermatology

title: Randomized, Placebo-controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib at 6 mg/kg/Day to Placebo in Treatment of Patients With Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis With Handicap

location_country:
United States
France


title: Multicentric Study of the Clinical Interest of the TcPO2 Technique

acronym: CINEYSOFT

summary:
The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded.

The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.

lead_sponsor: University Hospital, Angers

location_facility:
Hospital
University Hospital


title: Phase 2 of Sunitinib (Sutent) in Patients With Locally Advanced or Metastatic Anaplastic, Differentiated or Medullar Thyroid Cancer

acronym: THYSU

summary:
Due to arguments showing that angiogenesis could be involved in progression of metastatic thyroid carcinoma and to objective response during previous studies with sunitinib (an angiogenic oncology drug also known as Sutent), this study, THYSU, is justified to evaluate the efficacy of sunitinib in metastatic thyroid carcinoma. Furthermore, the standard treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is limited to radioiodine. When radioiodine becomes ineffective, there is no standard treatment despite some use of chemotherapy.

The objective of the trial is to determine the objective tumor response rate (efficacy) in patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid carcinoma treated with sunitinib; a secondary objective is to evaluate the safety of sunitinib in these patients.

The THYSU trial is a phase II, French multi-center study. This trial's plan is to enroll 75 patients with locally advanced or metastatic anaplastic, differentiated or medullar thyroid carcinoma.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Pfizer

location_facility: Service d'endocrinologie et Maladies Métaboliques, Groupe Hospitalier Rangueil-Larrey CHU Toulouse - avenue Prof Jean Poulhes

location_facility: Centre Léon Bérard - Département de Médecine - 28 rue Laennec

location_facility: Service des Maladies Endocriniennes - Hôpital Lapeyronie - 191 avenue du Doyen Gaston Giraud

location_facility: Centre Antoine Lacassagne - 33 avenue de Valombrose

location_facility: Service d'Endocrinologie et maladies métaboliques, Clinique Marc Linquette - rue du Pr Laguesse

location_facility: Service d'Endocrinologie - CHU de Nancy, Hôpital de Brabois - rue du Morvan

location_facility: Service d'Endocrinologie - Hôpital de l'Archet I - Route Saint Antoine de Jinestière

location_facility: Centre Paul Lamarque - Va d'Aurelle - CRLC Val d'Aurelle - 208 rue des Apothicaires

location_facility: Fédération Endocrinologie - Groupe Hospitalier Est - Hôpital neurologique - CHU Lyon - 59 Boulevard Pinel

location_facility: Service de Cancérologie Médicale - HEGP - 20 rue Leblanc

location_facility: Service d'Endocrinologie, CHU Timone, AP-HM - 254 rue St Pierre

location_facility: Service d'Oncologie Médicale, Institut Claudius Regaud - 20-24 rue du Pont Saint Pierre

location_facility: Département Endocrinolo-Diabéto-Nutrition - CHU d'Angers - 4 rue de Larray

location_facility: Service d'Oncologie Médicale et de Radiothérapie - Hôpital Saint André - 1 rue Jean Burguet


acronym: CAPADOGE

summary: The investigators will propose to older cancer patients with good prognosis (curative care) a randomized trial of adapted physical activity during one year. To increase generalisation of the intervention the investigators intend to compare the PNNS advices (the French National Nutrition and Health Program) to a program targeted on the own capacities of each patient.

location_facility:
CHU de Bordeaux - Hôpital Saint André
Institut Bergonié
CHU de Limoges, Hôpital Dupuytren
CHU Nancy hôpital adulte du brabois
CH de Dax
Centre Oscar Lambret, CLCC Lille
CHU Bordeaux - hôpital Xavier Arnozan
CHRU Lille
Centre Alexis Vautrin CLCC Nancy
Centre hospitalier de Senlis
CH Mont de Marsan
Institut jean Godinot, CLCC Reims


title: Alterations in Total Red Blood Cell Volume and Plasma Volume During a One-year Confinement in Antarctica: Effect of Hypoxia

acronym: ANTARCV

summary: This study evaluates the effect of hypoxia on blood volumes during Antarctic winter-over confinement. Half of the participants will be evaluated during sea-level winter-over confinement, while the other half will be examined during high-altitude hypoxia winter-over confinement.

status: Enrolling by invitation

primary_purpose: Basic Science

lead_sponsor: Ecole Nationale des Sports de Montagne

collaborators: Center for Physical Activity Research, University Hospital of Copenhagen, Denmark

collaborators: Laboratory Mobility, aging & exercise (MOVE) -EA 6314, Faculty of Sport Sciences, University of Poitiers, France

collaborators: Department for Biomedical Sciences for Health, University of Milan School of Medicine, Milan, Italy

collaborators: HP2 Laboratory, INSERM, Grenoble Alpes University, CHU Grenoble Alpes, Grenoble, France

location_facility: Ecole nationale des sports de montagne, site de l'Ecole nationale de ski et d'alpinisme


summary: The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population

lead_sponsor: Pierre Fabre Medical Devices


title: An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.

acronym: COMET

summary:
The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.

primary_purpose: Health Services Research

ReferenceCitation: Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

publisher_dissemination: Wiley

ReferenceCitation: Kessler R, Casan-Clara P, Koehler D, Tognella S, Viejo JL, Dal Negro RW, Diaz-Lobato S, Reissig K, Rodriguez Gonzalez-Moro JM, Devouassoux G, Chavaillon JM, Botrus P, Arnal JM, Ancochea J, Bergeron-Lafaurie A, De Abajo C, Randerath WJ, Bastian A, Cornelissen CG, Nilius G, Texereau JB, Bourbeau J. COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD. Eur Respir J. 2018 Jan 11;51(1):1701612. doi: 10.1183/13993003.01612-2017. Print 2018 Jan.

publisher_dissemination: European Respiratory Society

lead_sponsor: Air Liquide Santé International

collaborators: Lincoln Medical and Mental Health Center

location_country: Germany Italy Spain France

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord

location_facility: Azienda Ospedaliera, "Ospedale San Carlo Borromeo"

location_facility: Universitätsklinikum Ulm, - Klinik Innere Medizin II

location_facility: Centre Hospitalier d Antibes Juans-les-pins

location_facility: Hôpitaux Civils de Colmar - Hôpital Pasteur

location_facility: Azienda ULSS 22 - Ospedale di Bussolengo


title: Randomized Clinical Trial Evaluating the Efficacy of Methotrexate in Addition to Anti-H1 Versus Placebo and Anti-H1 in the Treatment of Severe Chronic Idiopathic Urticaria

acronym: MUCIS

summary: Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment consists of anti-H1 molecules. In severe cases, refractory to anti-H1, few therapeutic alternatives exist. Methotrexate, which is not expensive and often prescribed by dermatologists, has been efficiently tried in an open study on severe chronic idiopathic urticaria, and also in few case reports.

lead_sponsor: University Hospital, Tours

location_facility:
Chru Nantes
Chu Mondor
CHRU LILLE Huriez
CHRU RENNES Pontchaillou
Hopital TENON
Chru Reims
CHRU BREST Morvan
Chru Tours
CHRU NANCY Brabois
CHRU POITIERS La Miléterie
Ch Le Mans


title: Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial

summary: To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.

ReferenceCitation: Nuytens F, Dabakuyo-Yonli TS, Meunier B, Gagniere J, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrere N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Markar SR, Piessen G; Federation de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Groups. Five-Year Survival Outcomes of Hybrid Minimally Invasive Esophagectomy in Esophageal Cancer: Results of the MIRO Randomized Clinical Trial. JAMA Surg. 2021 Apr 1;156(4):323-332. doi: 10.1001/jamasurg.2020.7081.

publisher_dissemination: American Medical Association

ReferenceCitation: Mariette C, Markar SR, Dabakuyo-Yonli TS, Meunier B, Pezet D, Collet D, D'Journo XB, Brigand C, Perniceni T, Carrere N, Mabrut JY, Msika S, Peschaud F, Prudhomme M, Bonnetain F, Piessen G; Federation de Recherche en Chirurgie (FRENCH) and French Eso-Gastric Tumors (FREGAT) Working Group. Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer. N Engl J Med. 2019 Jan 10;380(2):152-162. doi: 10.1056/NEJMoa1805101.

ReferenceCitation: Briez N, Piessen G, Bonnetain F, Brigand C, Carrere N, Collet D, Doddoli C, Flamein R, Mabrut JY, Meunier B, Msika S, Perniceni T, Peschaud F, Prudhomme M, Triboulet JP, Mariette C. Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial. BMC Cancer. 2011 Jul 23;11:310. doi: 10.1186/1471-2407-11-310.

lead_sponsor: University Hospital, Lille

location_facility:
Hopitaux Universitaires de Strasbourg
Hopital Du Haut Leveque
Hopital Ambroise Pare Ap-Hp
Hotel Dieu
Hopital St Marguerite Ap-Hm
Hopital St Louis Ap-Hp
Institut Mutualiste Montsouris
Hopital de La Croix Rousse
Hopital Purpan
Hopital Louis Mourier
Hopitalpontchaillou


title: Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.

summary: The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle

primary_purpose: Other

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Guidant Corporation

location_facility:
Nouvelle Clinique Nantaise
CH Amiens
HEGP
CH St. Joseph
CHU Nantes
CHU Lariboisière
CHU Henri Mandor
CH Besancon
CHU Montpellier
Hôpital Pontchaillou
CHU La Timone
CHU Michalon
CHU Rouen
CHU Clermont Ferrand
CHU Tours
CHU Pitié Salpitrière
CHU Angers
CHU Rangueil


title: Pain Intensity After RObotic Assisted Urological Surgery: the PAIROU Study

acronym: PAIROU

summary:
Postoperative pain remains a widespread but still underestimated problem. Studies have shown that despite improvements in pain management, many patients still suffer from moderate to severe postoperative pain. Severe pain is associated with decreased patient satisfaction, delayed postoperative ambulation, prolonged length of stay, risk of developing chronic postoperative pain, and increased morbidity and mortality. Therefore, it is of great importance that surgical procedures that result in severe pain and the optimal analgesic strategies for these procedures can be identified. Most recommendations on postoperative pain management (prevention and treatment) are not procedure-specific. However, risk factors for postoperative pain depend on the patient and the procedure.

In order to develop procedure-specific postoperative pain management guidelines, pain must be assessed in a procedure-specific manner. Additionally, data is sparse on relatively new procedures like robotic surgery. A study, Harel et al. compared pain intensities after ureteral reimplantation with robotic or open surgery in children and reported lower pain scores after robotic surgery. This single study reinforces the clinical findings that robotic surgery is associated with less pain. However, pain assessment after robotic urologic surgery has not been evaluated before.

In order to add to the evaluation of postoperative pain in different surgical groups, we wish to evaluate pain intensities after robot-assisted urological surgery. In this cohort study, we seek to provide an estimate of the pain intensities that can be expected after most types of robot-assisted urological surgery in relation to analgesic treatment.

ReferenceCitation: Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

ReferenceCitation: Aubrun F, Nouette-Gaulain K, Fletcher D, Belbachir A, Beloeil H, Carles M, Cuvillon P, Dadure C, Lebuffe G, Marret E, Martinez V, Olivier M, Sabourdin N, Zetlaoui P. Revision of expert panel's guidelines on postoperative pain management. Anaesth Crit Care Pain Med. 2019 Aug;38(4):405-411. doi: 10.1016/j.accpm.2019.02.011. Epub 2019 Feb 26.

ReferenceCitation: Panzenbeck P, von Keudell A, Joshi GP, Xu CX, Vlassakov K, Schreiber KL, Rathmell JP, Lirk P. Procedure-specific acute pain trajectory after elective total hip arthroplasty: systematic review and data synthesis. Br J Anaesth. 2021 Jul;127(1):110-132. doi: 10.1016/j.bja.2021.02.036.

ReferenceCitation: Harel M, Herbst KW, Silvis R, Makari JH, Ferrer FA, Kim C. Objective pain assessment after ureteral reimplantation: comparison of open versus robotic approach. J Pediatr Urol. 2015 Apr;11(2):82.e1-8. doi: 10.1016/j.jpurol.2014.12.007. Epub 2015 Feb 26.

ReferenceCitation: Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_country: Spain Belgium France

location_facility: AP-HP - Groupe Hospitalier Pitié-Salpêtrière - APHP

location_facility: Hôpital Privé de la Châtaigneraie - Beaumont

location_facility: Polyclinique Sainte Marguerite - Institut d'Urologie- Auxerre

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille

location_facility: Centre Hospitalier Intercommunal Toulon-La Seyne sur mer

location_facility: Centre Hospitalier Dubois - Brive la Gaillarde


title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.

ipd_sharing: Yes

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Finland
Italy
Lithuania
Slovenia
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Belgium
Spain
Greece
Czechia
France

location_facility: CHU-Pôle Médico-Chirurgical de l'Enfant et l'Adolescant

location_facility: Azienda ospedaliero universitaria di Parma

location_facility: Children's Cancer & Haematology Services, John Hunter Children's Hospital

location_facility: Ospedale San Giovanni Pediatria, Emato-oncologia pediatrica

location_facility: General Hospital of Thessaloniki "IPPOKRATIO"

location_facility: Azienda ospedaliero universtaria Anna Meyer

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Australian and New Zealand Children's Hematology/oncology Group

location_facility: Children's General Hospital "P. & A. KYRIAKOU"

location_facility: Hospital Universitario Politécnico de La FE

location_facility: Ostschweizer Kinderspital Hämatologie/Onkologie Claudiusstrasse 6

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Institut de cancérologie de l'Ouest - Sité René Gauducheau

location_facility: Children's General Hospital "I AGHIA SOFIA"

location_facility: Groupe Hospitalier Pellegrin - Chu - Bordeaux

location_facility: Cliniques Universitaires Saint-Luc (UCL)

location_facility: Hôpital de la Mère et de l'Enfant - CHU Limoges

location_facility: Children's General Hospital "AGHIA SOFIA"

location_facility: U.O Pediatria, SS Oncoematologia pediatrica

location_facility: Spedali civili Ospedale Dei Bambini Oncoematologia pediatrica e TMO

location_facility: Hospital Regional Universitario de Málaga

location_facility: Hospital Universitario Infantil Niño Jesús

location_facility: University Hospitals Birmingham Queen Elisabeth Hospital(UHB)

location_facility: Karolinska University Hospital, Stockholm

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: New Children's Hospital, Helsinki University Hospital, Helsinki and Uusimaa Hospital District

location_facility: University General Hospital of Thessaloniki "AHEPA"

location_facility: Inselspital, Universitätsklinik für Kinderheilkunde

location_facility: U.O.C oncoematologia pediatrica ospedale Donna Bambino

location_facility: University General Hospital of Heraklion (UnGHH)

location_facility: Division of Pediatric Oncology Universitäts-Kinderspital Zürich

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois

location_facility: Luzerner Kantonsspital, Kinderspital pädiatrische Hämatologie/Onkologie

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: Oncology/Haematology Department, Perth Children's Hospital

location_facility: Kantonsspital Aarau AG Klinik für Kinder und Jugendliche

location_facility: The Hans Christian Andersen Children's Hospital, University of Southern Denmark

location_facility: Hôpital Universitaire des Enfants Reine Fabiola (ULB)

location_facility: University medical center Ljubljana, University Children's Hospital Ljubljana, Slovenia

location_facility: University Hospital Northern Norway, Tromsoe

location_facility: HUG Hôpitaux Universitaires de Genève Unité d'Hémato-Oncologie Pédiatrique

location_facility: Cancer Centre for Children, The Children's Hospital

location_facility: "MITERA" Private, General, Obstetrics - Gynaecology, Paediatric Clinic S.A.

location_facility: Children's Cancer Centre, Monash Children's Hospital

location_facility: Department of Paediatrics and Adolescent Medicine, Rigshospitalet


title: Clinical Impact of the iBox as an Early Intervention tooL: A Prospective Randomised Controlled Trial to Assess the Use of a Software Predicting Allograft Survival in the Follow-up of Kidney Transplanted Patients.

summary: International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.

ipd_sharing_description: Data will be communicated to other researchers in an aggregated manner

location_country:
Germany
France
United Kingdom
Austria
Spain
Israel

location_facility: Guy's & Saint Thomas' NHS Foundation Trust

location_facility: Sourasky Medical Center - Ichilov Hospital

location_facility: Hospital Universitari i Politècnic La Fe


title: Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

acronym: MVP

summary: Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
University Hospital, Brest
Rennes University Hospital

location_facility:
Brest University Hospital
Rennes University Hospital
Nantes University Hospital


title: A Phase I/II Study of Eltrombopag in Patients With Chronic Myelomonocytic Leukemia and Thrombocytopenia

summary: Treatment of patients with chronic myelomonocytic leukemia (CMML) and thrombocytopenia.

lead_sponsor: Groupe Francophone des Myelodysplasies

collaborators: GlaxoSmithKline Novartis

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
GlaxoSmithKline
Novartis

location_facility: IUCT Oncopole - Service d'Hématologie Clinique

location_facility: Hôpital Saint Louis - Service d'hématologie AJA

location_facility: Hôpital Saint Louis - Service d'hématologie séniors

location_facility: Centre Hospitalier de la région d'Annecy


title: A Phase I-II Trial of Acadesine in IPSS High and Int-2 SMD, LAM With 20-30% Marrow Blasts and CMML Type 2 Not Responding to Azacitidine or Decitabine for at Least 6 Courses or Relapsing After a Response

acronym: Acadesine

summary:
A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to Azacitidine or Decitabine for at least 6 courses or relapsing after a response:

Patients will receive 6 treatment cycles unless disease progression, transformation, or unacceptable toxicity occurs, or the patient refuses to continue participating in the study.

Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles, patients demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with cycles of Acadesine (at the same dose as in the preceding cycles, depending on their cohort) until progression.

collaborators: Advancell - Advanced In Vitro Cell Technologies, S.A.

location_facility:
Hôpital Avicenne
Centre henri Mondor
Institut paoli calmettes
CHU de nantes
Hôpital L'archet 1, Nice
Hôpital Saint Antoine
Hôpital Saint-Louis
Hôpital Cochin
Centre Antoine Lacassagne
Centre hospitalier de la côte Basque
Hôpital Saint Louis
Centre henri Becquerel
Hôpital Bretonneau de Tours
CHU de Limoges
CHU de Grenoble
CHU de Haut-Lévèque
centre hospitalier de Meaux


title: Identification and Prevention of Sudden Cardiac Death Causes in Hemodialysis Patients

acronym: RYTHMODIAL

summary: The purpose of this study is to use implantable loop recorder (ILR) in patients under chronic hemodialysis to record arrhythmias and conduction disorders and correlate them with hemodialysis parameters.

ReferenceCitation: Sacher F, Jesel L, Borni-Duval C, De Precigout V, Lavainne F, Bourdenx JP, Haddj-Elmrabet A, Seigneuric B, Keller A, Ott J, Savel H, Delmas Y, Bazin-Kara D, Klotz N, Ploux S, Buffler S, Ritter P, Rondeau V, Bordachar P, Martin C, Deplagne A, Reuter S, Haissaguerre M, Gourraud JB, Vigneau C, Mabo P, Maury P, Hannedouche T, Benard A, Combe C. Cardiac Rhythm Disturbances in Hemodialysis Patients: Early Detection Using an Implantable Loop Recorder and Correlation With Biological and Dialysis Parameters. JACC Clin Electrophysiol. 2018 Mar;4(3):397-408. doi: 10.1016/j.jacep.2017.08.002. Epub 2017 Sep 27.

location_facility:
CH de Libourne
University Hospital of Bordeaux
CH de Haguenau
CHU de Toulouse
CHU de Strasbourg
Clinique Saint Augustin
CHU de Rennes
Polyclinique Bordeaux-Nord Aquitaine
CHU de Nantes


title: Prospective Therapeutic De-escalation and miRNA-M371 Biomarker Evaluation Phase II Study for Stage IIa/IIb < 3 cm Seminomas

acronym: EDEN

summary:
Phase II, multicenter, prospective, randomized, non-comparative, de-escalation study.

Patients with stage IIa/IIb < 3 cm seminoma histologically proved after orchiectomy will be included in the study and will receive 1 cycle of Etoposide Cisplatine (EP) chemotherapy.

Patients with negative week-3 PET-scan after the EP cycle, will be randomized (1:1 ratio, stratification according to the disease stage (stage IIa versus IIb seminoma)) to receive either radiotherapy (RT) boost on lymph nodes or 1 cycle of carboplatin AUC7 chemotherapy.

Patients with positive week-3 PET-scan will received 3 additional cycles of EP chemotherapy.

In parallel, eligible patients scheduled to receive standard lombo-aortic RT will be registered in an observational cohort.

lead_sponsor: Centre Leon Berard

location_facility: Institut Universitaire de Cancer de Toulouse (IUCT-O)


title: A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR

acronym: FLARE

summary:
The current first line treatment of patients with EGFR activating mutation lung cancer is EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of response rate and progression-free survival. However, an acquired resistance occurs almost constantly. The second-line treatment includes platinum-based chemotherapy in the absence of contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs.

However, a rebound phenomenon of the disease was described in patients who discontinued EGFR TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI acquired resistance.

It seems therefore useful to conduct a study to better define the therapeutic strategy to adopt in patients developing an acquired resistance after having received EGFR TKIs as first line treatment.

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
Groupe Francais De Pneumo-Cancerologie
Hoffmann-La Roche

location_facility: Hôpital d'instruction des Armées Sainte-Anne


title: Triple-site Biventricular Stimulation in the Optimization of Cardiac Resynchronization Therapy (CRT)

acronym: TRIUMPH-CRT

summary:
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation.

Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation.

Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.

lead_sponsor: MicroPort CRM

location_country: Germany Italy Portugal Netherlands Spain France


title: A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent

summary: The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent.

location_facility:
Chu Estaing
Chu Morvan
Hopital Felix Guyon
CHU
Hopital Trousseau
CHRU
Centre Oscar Lambret
Institut Gustave Roussy
Hopital de La Timone
Institut Curie


title: A Randomized, Open Label, Phase II Trial of Bevacizumab Plus Weekly Paclitaxel Followed by Bevacizumab Monotherapy Maintenance Versus Weekly Paclitaxel Followed by Observation in Patients With Relapsed Ovarian Sex-cord Stromal Tumours

acronym: ALIENOR

summary:
Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood vessels (a process called "angiogenesis"). This can reduce blood flow of the tumor and then decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the tumor from growing.

In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already benefits from a marketing authorization (MMA) for these various types of cancers.

The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is ended.

This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal since this tumors are very well vascularized.

The ALIENOR study aims to explore the interest and the clinical benefit of associating bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords- stromal tumor treated beforehand by platinum chemotherapy

ReferenceCitation: Ray-Coquard I, Harter P, Lorusso D, Dalban C, Vergote I, Fujiwara K, Gladieff L, Luck HJ, Floquet A, Chevalier-Place A, Schnelzer A, Pignata S, Selle F, Sehouli J, Brocard F, Mangili G, Pautier P, De Giorgi U, Provansal M, Heudel PE. Effect of Weekly Paclitaxel With or Without Bevacizumab on Progression-Free Rate Among Patients With Relapsed Ovarian Sex Cord-Stromal Tumors: The ALIENOR/ENGOT-ov7 Randomized Clinical Trial. JAMA Oncol. 2020 Dec 1;6(12):1923-1930. doi: 10.1001/jamaoncol.2020.4574.

lead_sponsor: ARCAGY/ GINECO GROUP

sponsor_collaborators:
ARCAGY/ GINECO GROUP
Roche Pharma AG

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: ICL Institut de Cancérologie de Lorraine