title: Tailored Multicomponent Program for Discomfort Reduction in Critically il Patients May Decrease Post-traumatic Stress Disorder in General ICU Survivors at One Year

acronym: PTSD-REA

summary:
Reducing discomfort in the intensive care unit (ICU) should be beneficial to longterm outcomes. This study assesses whether a tailored multicomponent program for discomfort reduction may be effective in reducing post-traumatic stress disorder (PTSD) symptoms at 1-year in general ICU survivors.

The psychiatric morbidity may be increased by the COVID-19 epidemic and its consequences on the healthcare system (patient care, reorganization of French ICUs). The main objective of PTSD-REA_COVID cohort is to assess this psychiatric morbidity 6 months after an ICU stay during the epidemic period.

ReferenceType: result

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lead_sponsor: Centre Hospitalier of Chartres

location_facility: Gaston Cordier_GH La Pitié-Salpêtrière-Charles Foix_APHP

location_facility: Husson Mourier_GH La Pitié-Salpêtrière-Charles Foix_APHP

location_facility: Hôpital de Hautepierre_CHU de Strasbourg


title: Transcranial Ultrasonography for the Management of Patients With Mild Traumatic Brain Injury

acronym: TRUST

summary: The investigators hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED. The targeted population is the category of patients eligible for early discharge: 1) patients with mild lesions on the initial CT scan and a GCS 15 after CT scan completion and, 2) patients with no lesion on the initial cerebral CT scan with at least one of the following risk factors: GCS 14 after CT scan completion, persisting post-traumatic nausea/vomiting/headaches, concomitant alcoholic intoxication or patients treated with aspirin. The study will not include mild TBI patients who are not eligible for early discharge: patients with no possibility of home supervision, those with a GCS lower than 14 after the CT scan or those treated with anticoagulant/antiplatelet drugs other than aspirin. The investigators expect the TCD-based strategy to be non-inferior compared to the standard strategy according to French recommendations in terms of the 3-months neurological outcome. From a public health standpoint, the use of TCD as a triage tool may change current guidelines regarding mild TBI management.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Büki A, Chesnut RM, Citerio G, Coburn M, Cooper DJ, Crowder AT, Czeiter E, Czosnyka M, Diaz-Arrastia R, Dreier JP, Duhaime AC, Ercole A, van Essen TA, Feigin VL, Gao G, Giacino J, Gonzalez-Lara LE, Gruen RL, Gupta D, Hartings JA, Hill S, Jiang JY, Ketharanathan N, Kompanje EJO, Lanyon L, Laureys S, Lecky F, Levin H, Lingsma HF, Maegele M, Majdan M, Manley G, Marsteller J, Mascia L, McFadyen C, Mondello S, Newcombe V, Palotie A, Parizel PM, Peul W, Piercy J, Polinder S, Puybasset L, Rasmussen TE, Rossaint R, Smielewski P, Söderberg J, Stanworth SJ, Stein MB, von Steinbüchel N, Stewart W, Steyerberg EW, Stocchetti N, Synnot A, Te Ao B, Tenovuo O, Theadom A, Tibboel D, Videtta W, Wang KKW, Williams WH, Wilson L, Yaffe K; InTBIR Participants and Investigators. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017 Dec;16(12):987-1048. doi: 10.1016/S1474-4422(17)30371-X. Epub 2017 Nov 6. Review.

ReferenceCitation: Tagliaferri F, Compagnone C, Korsic M, Servadei F, Kraus J. A systematic review of brain injury epidemiology in Europe. Acta Neurochir (Wien). 2006 Mar;148(3):255-68; discussion 268. Review.

ReferenceCitation: Davis DP, Kene M, Vilke GM, Sise MJ, Kennedy F, Eastman AB, Velky T, Hoyt DB. Head-injured patients who "talk and die": the San Diego perspective. J Trauma. 2007 Feb;62(2):277-81.

ReferenceCitation: af Geijerstam JL, Britton M. Mild head injury: reliability of early computed tomographic findings in triage for admission. Emerg Med J. 2005 Feb;22(2):103-7. Review.

ipd_sharing: No

lead_sponsor: University Hospital, Grenoble

location_country: France Monaco

location_facility:
CHU Nantes
CHU Grenoble Alpes
CH Bourg-en-bresse
AP-HP Lariboisière
CHU Clermont-Ferrand
CHU Poitiers
CHU Toulouse
HCL - Lyon Sud
AP-HM Timone
CH Melun
CHU Nîmes
AP-HP - Avicenne
CHU Réunion
CHRU Montpellier
HCL - Edouard Herriot
CH Monaco
CHRU Lille
AP-HP Pitié Salpetrière
Chu Reunion

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery: IMPROVE-2 Multicenter Prospective Randomized Trial

summary: The aim of this study is to compare the effects of a strategy aimed at increasing alveolar recruitment (high PEEP levels adjusted according to driving pressure and recruitment maneuvers) with that of a strategy aimed at minimizing alveolar distension (low PEEP level without recruitment maneuver) on postoperative respiratory failure and mortality in patients receiving low VT ventilation during emergency abdominal surgery.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Khaled L, Godet T, Jaber S, Chanques G, Asehnoune K, Bourdier J, Araujo L, Futier E, Pereira B. Intraoperative protective mechanical ventilation in patients requiring emergency abdominal surgery: the multicentre prospective randomised IMPROVE-2 study protocol. BMJ Open. 2022 May 6;12(5):e054823. doi: 10.1136/bmjopen-2021-054823.

ipd_sharing: Yes

ipd_sharing_description:
The French National Data Safety Authority (CNIL) forbids making data freely available without prior agreement. Thus, the data underlying study findings cannot be made freely available because of ethical and legal restrictions. However, individual participant data underlying the results reported in the manuscript (text, tables, figures, and appendices) can be obtained after deidentification. Data can be obtained upon request from the IMPROVE-2 steering committee. Readers may contact: efutier@chu-clermontferrand.fr to request the data.

The data cannot be freely available for the reasons mentioned above. Data access can be only possible after scientific assessment and data sharing agreement, detailing the type of data requested. This data sharing agreement has to be signed between applicants and the sponsor, Clermont-Ferrand University Hospital.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Assistance Publique-Hôpitaux de Marseille

intervention_type: Other

status_simplified: Completed


title: IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.

summary:
Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available.

Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA.

As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie

location_facility: Centre Hospitalier Orleans-Hopital La Source

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Centre Hospitalier de Bigorre Site La Gespe

location_facility: Centre Hospitalier Universitaire de Lille - Hopital B Roger Salengro

location_facility: Centre Hospitalier Universitaire Saint Etienne Hopital Nord

location_facility: Centre Hospitalier des Deux Vallees Juvisy

location_facility: Clinique de La Sauvegarde / Cabinet Le Trait D Union

location_facility: Centre Hospitalier Montceau Les Mines-Hopital Jean Bouveri

location_facility: Centre Hospitalier Annecy Genevois Site Annecy

location_facility: Centre Hospitalier Departemental Vendee Les Oudairies

intervention_type: Drug

lead_sponsor_type: industriel


title: Management of Paroxystic Atrial Fibrillation in French Intensive Care Units

acronym: PAF-ICU

summary: The primary purpose of the study is to evaluate treatment of new onset atrial fibrillation in french ICU.

location_facility: Institut Régional du Cancer de Montpellier


title: Phase III Randomized Trial of Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Monthly Carboplatin With Weekly Paclitaxel Chemotherapy

acronym: ELDERLY

summary: Non Small Cell Lung Cancer (NSCLC) remains the leading cause of death by cancer in the world. Because of the increase in lung cancer incidence with age and the increase of life expectancy, about half of the patients are patients aged 70 or older. Several clinical trials have shown the interest of adding immunotherapy to standard 1st line chemotherapy in NSCLC. Although in these studies there was not necessarily a higher age limit, in fact the proportion of included patients aged 75 or older remains low (between 7 and 10%). It is therefore necessary to conduct a trial dedicated to these patients in order to determine whether immunotherapy is as effective and tolerated as in the general population.

ReferenceCitation: Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavolé A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducoloné A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancérologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.

ipd_sharing: Undecided

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Quint-Fonsegrives - Clinique de la Croix du Sud

location_facility: Saint-Priest - Institut de Cancérologie de la Loire

location_facility: Villefranche-Sur-Saône - Hôpital Nord-Ouest

location_facility: Nancy - Institut de Cancérologie de Lorraine


acronym: TOPICAL

title: 0.1% Topical Sirolimus in the Treatment of Cutaneous Microcystic Lymphatic Malformations in Children and Adults: Phase II, Split-body Randomized, Double-blind, Vehicle-controlled Clinical Trial

lead_sponsor: University Hospital, Tours

type: EudraCT Number

source: euctr

ReferenceCitation: Leducq S, Caille A, Barbarot S, Bénéton N, Bessis D, Boccara O, Bursztejn AC, Chiaverini C, Dompmartin A, Droitcourt C, Gissot V, Goga D, Guibaud L, Herbreteau D, Le Touze A, Léauté-Labrèze C, Lorette G, Mallet S, Martin L, Mazereeuw-Hautier J, Phan A, Plantin P, Quéré I, Vabres P, Bourgoin H, Giraudeau B, Maruani A; Groupe de Recherche de la Société Française de Dermatologie Pédiatrique. Topical sirolimus 0.1% for treating cutaneous microcystic lymphatic malformations in children and adults (TOPICAL): protocol for a multicenter phase 2, within-person, randomized, double-blind, vehicle-controlled clinical trial. Trials. 2019 Dec 17;20(1):739. doi: 10.1186/s13063-019-3767-8.

location_facility:
QUIMPER
NANTES
NICE
NANCY
ANGERS
BORDEAUX
LYON AD
TOURS
DIJON
NECKER
RENNES
Marseille
Lariboisiere
TOULOUSE
Montpellier
CAEN
LYON PED

summary: Cutaneous microcystic lymphatic malformations (CMLMs) are rare conditions of children and adults resulting from abnormal embryologic development of lymphatic vessels. They present as clusters of vesicles full of lymph and blood of various extent. They ooze and bleed, inducing maceration, esthetic impairment, scars, pain, bacterial infections and impaired quality of life. Currently, treatments for CMLMs are disappointing, and their management is challenging. Sirolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine/threonine protein kinase involved in cell growth and proliferation, cellular metabolism, autophagy and angio-lymphangiogenesis. Topical sirolimus, known to be efficient and well tolerated in cutaneous angiofibromas linked to tuberous sclerosis, has recently been reported effective in few reports of patients with CMLMs. The objective of this trial is to compare the efficacy and safety of a 12-week application of 0.1% topical sirolimus versus topical vehicle in CMLMs in children and adults.


title: Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis

acronym: KlebsieLCR

summary: Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia <10mg / dL and proteinuria> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.

time_perspective: Retrospective

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
CHU Nantes
CHU Tours
CHU Lyon
Hôpital Necker Enfants Malades
CHU Kremlin Bicetre
Hôpital Sainte Anne
CHU Strasbourg
CHU Caen
Hôpital henri Mondor
Groupe Hospitalier Paris Saint-Joseph
CHU Brest
Hôpital Foch
CHU Poitiers
CHU Rennes
Hôpital Cochin
CHU Reims
CHU Nice
Hôpital Lariboisière


title: A Prospective Study Assessing Whether Immunoscore Colon Test Impacts the Choice of Adjuvant Chemotherapy, in a Multidisciplinary Meeting, for Treating Non-metastatic Colon Cancer Patients After Curative-intent Surgery

acronym: PROSCORE

summary: Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.

study_start_date_type: Anticipated

status: Withdrawn

primary_purpose: Diagnostic

ReferenceCitation: Pagès F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Börger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grützmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Léonard D, Remue C, Wang JY, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Angelova M, Vasaturo A, Maby P, Church SE, Angell HK, Lafontaine L, Bruni D, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Meyers JP, Paustian C, Feng Z, Ballesteros-Merino C, Dijkstra J, van de Water C, van Lent-van Vliet S, Knijn N, Mușină AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Itoh K, Patel PS, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Sargent DJ, Fox BA, Galon J. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018 May 26;391(10135):2128-2139. doi: 10.1016/S0140-6736(18)30789-X. Epub 2018 May 10.

lead_sponsor: UNICANCER

intervention_type: Diagnostic Test

status_simplified: Unknown


acronym: GEMPAX

title: A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

location_facility:
Hôpital Broussais
Centre Georges François Leclerc
Hôpital Européen de Marseille
Hôpital Nord Franche Comté
Institut Mutualiste Montsouris
CH Simone Veil
Centre Antoine Lacassagne
Institut de Cancérologie de l'Ouest
Centre Léon Bérard
Hôpital Pitié-Salpétrière
Institut Gustave Roussy
Hôpital Saint-Louis
CH de Bayeux
CHU Rouen
Institut Godinot
Institut Curie
CHU La Timone
CHU Jean Minjoz
Hôpital Saint-Joseph
CH du Cotentin
Institut Paoli Calmettes
Hôpital Duchenne
Hôpital Trousseau
CHU de Saint-Etienne
Centre Eugène Marquis
Hospices civils de Lyon

summary: This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.


title: BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation

summary:
Blinatumomab (BLINCYTO) is a bi-specific T-cell engaging (BiTE®) antibody construct that transiently links CD3-positive T cells to CD19-positive B-cells, inducing T-cell activation and subsequent lysis of tumor cells.

The investigators propose to evaluate the efficacy, safety and tolerability of blinatumomab administered after R-CHOP debulking therapy in patients with Richter Syndrome (RS) of diffuse large B-cell lymphoma (DLBCL) histology.

The investigators hypothesize that 8-week blinatumomab induction therapy leads to Complete Response (CR) rate improvement (revised Cheson criteria) from a baseline of 7percent as observed in the prospective study evaluating R-CHOP.

status: Active, not recruiting

lead_sponsor: French Innovative Leukemia Organisation

location_facility: Hôpital Avicenne - Centre de Recherche Clinique

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Robert Debré - Hématologie Clinique

location_facility: Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: Hôpitaux de Brabois - Hématologie Adulte

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: Institut Paoli-Calmettes - Hématologie Clinique


title: OPEN LABEL PHASE 2 STUDY ON THE EFFICACY AND TOLERANCE OF A COMBINATION OF PONATINIB AND 5-AZACITIDINE IN CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS - PONAZA TRIAL

acronym: PONAZA

summary:
This project is strategy aiming to improve the survival of patients with chronic myelogenous leukemia in advanced phase and myeloid blast crisis.

The basis of this strategy is to add the demethylating agent 5-Azacitidine to the tyrosine kinase inhibitor ponatinib and evaluate its activity in 2 cohorts of patients with either chronic myelogenous leukemia in advanced phase or myeloid blast crisis.

design_allocation: Non-Randomized

lead_sponsor: Versailles Hospital

location_facility: Centre Hospitalier Universitaire D'Amiens

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Institut Universitaire Du Cancer Toulouse

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Centre Hospitalier Universitaire de Rennes


title: A Phase III Randomized Trial Evaluating Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer (GRECCAR - PRODIGE - FRENCH)

summary:
GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. The widespread use of neoadjuvant radiotherapy for primary rectal cancer introduces this new problem: the treatment of LRRC in previously irradiated area.

The objective of GRECCAR 15 is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.

ReferenceCitation: Denost Q, Frison E, Salut C, Sitta R, Rullier A, Harji D, Maillou-Martinaud H, Rullier E, Smith D, Vendrely V; on behalf the GRECCAR Group. A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as preoperative treatment for locally recurrent rectal cancer - GRECCAR 15 trial protocol. Colorectal Dis. 2021 Jul;23(7):1909-1918. doi: 10.1111/codi.15670. Epub 2021 Jun 10.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Européen Georges Pompidou - APHP

intervention_type: Radiation


type: Registry Identifier

title: PALbociclib in Advanced Breast Cancer: Therapy INtegrating locorEgional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients

acronym: PALATINE

summary:
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after lung cancer and the world's leading cause.

In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone receptor (HR)-positive / HER2-negative breast cancer.

The most important current treatment for metastatic breast cancer remains systemic therapy. Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS. These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy. Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor.

Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results. This can be explained by a limited power of statistical analysis, on the recruitment of patients with breast cancer of all types, and on a limited access to effective systemic therapies in some cases and all before the area of anti CD4/6 which is the current standard treatment in patients with HR-positive / HER2-negative luminal metastatic disease.

However, guidelines indicate that a "multimodal approach, including curative locoregional treatments, should be considered". As a result, many clinicians offer locoregional treatment of the primary tumor, especially if there is a good response to the first line of systematic treatment.

Taken together, these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive / HER2-negative breast cancer.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_facility: GCS RISSA - Institut de cancérologie Paris Nord

location_facility: Institut de Cancérologie de l'Ouest-Site Paul Papin


title: Phase II Trial of Trastuzumab in Combination With Pertuzumab in Pretreated Patients With Non-small Cell Lung Cancer (NSCLC) Harboring a Her2 Mutation and Receiving Docetaxel

summary: HER2 (erbB-2/neu) is a member of the erbB receptor tyrosine kinase family. ERBB2 gene which encodes human epidermal growth factor 2 (HER2) is a major proliferative driver activating downstream signaling through PI3K-AKT and MEK-ERK. HER2 overexpression or gene amplification is associated with sensitivity to trastuzumab and lapatinib in breast cancer. Among actual lung cancer biomarker, HER2 remains apart. HER2 involvement is known for a long time but clinical research has been stopped for many years since the first clinical trials in unselected patients were negative. Recently trastuzumab + pertuzumab + docetaxel has been tested for first-line treatment of HER2-positive metastatic breast cancer (CLEOPATRA trial). Analysis of the primary end point showed that patients who received pertuzumab, trastuzumab, and docetaxel (pertuzumab group) had a significantly longer median progression-free survival, as assessed by independent reviewers an did those who received placebo, trastuzumab, and docetaxel (control group) (hazard ratio favoring the pertuzumab group, 0.62). There is thus a strong rational for treating HER2 mutated lung cancer patient with these drugs.

ReferenceCitation: Mazieres J, Lafitte C, Ricordel C, Greillier L, Negre E, Zalcman G, Domblides C, Madelaine J, Bennouna J, Mascaux C, Moro-Sibilot D, Pinquie F, Cortot AB, Otto J, Cadranel J, Langlais A, Morin F, Westeel V, Besse B. Combination of Trastuzumab, Pertuzumab, and Docetaxel in Patients With Advanced Non-Small-Cell Lung Cancer Harboring HER2 Mutations: Results From the IFCT-1703 R2D2 Trial. J Clin Oncol. 2022 Mar 1;40(7):719-728. doi: 10.1200/JCO.21.01455. Epub 2022 Jan 24.

location_facility:
CHU Besançon
Clermont-Ferrand - CHU
Rennes - CHU
Lyon - URCOT
Montpellier - CHRU
AP-HP Hopital Tenon - Pneumologie
CHU Strasbourg
Caen - CHU Côte de Nacre
CHU de Nantes
AP-HP Hôpital Bichat
CHU Toulouse
Gustave Roussy
CHRU Grenoble
CHU de Bordeaux
CHI Créteil
Centre Hospitalier - Pneumologie
Nice CLCC
Hôpital Nord APHM


title: A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

summary: To evaluate the clinical benefit of a post-operative adjuvant therapy combining radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine in Triple Negative Breast Cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy.

lead_sponsor: Centre Leon Berard

location_facility:
Centre d'Oncologie Radiothérapie 37
Hopital Prive Jean Mermoz
Institut Jean Godinot
Centre Paul Strauss
Institut Paoli Calmettes
Centre Antoine Lacassagne
Hôpital Drôme Ardèche
CHRU Besançon
Institut de Cancérologie de l'Ouest
Centre Francois Baclesse
Centre Léon Bérard
Clinique de la Sauvegarde
GH Pitié-Salpêtrière-Charles Foix
Institut Curie
Institut Sainte Catherine


title: A Randomized Non-comparative Phase II Study of Maintenance Therapy With OSE2101 Plus FOLFIRI, or FOLFIRI After Induction Therapy With FOLFIRINOX in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (TEDOPaM-D17-01 PRODIGE 63 Study)

acronym: TEDOPAM

summary: TEDOPAM is a randomized (1.1.1) non-comparative phase II study. This study will assess the efficacy and safety of OSE2101 alone or in combination with nivolumab followed by FOLFIRI reintroduction, versus FOLFIRI as maintenance therapy in patients with advanced PDAC after induction therapy with FOLFIRINOX.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Hôpital Lyon Sud Hospices Civils de Lyon


title: Personalized Medicine for Membranous Nephropathy

acronym: PMMN

summary:
Randomized, open label, multicentre (20 sites), prospective trial comparing the efficacy of two therapeutic strategies to obtain clinical remission 1 year after diagnosis of Idiopathic Membranous Nephropathy with nephrotic syndrome and anti-PLA2R1 (phospholipase A2 receptor 1) antibodies:

GEMRITUX protocol: 6 months of symptomatic antihypertensive and antiproteinuric therapy, and if the nephrotic syndrome persists at month-6 (urinary protein/creatinine ratio (UPCR) remains > 3.5 g/g and albuminemia < 30 g/l), two 375 mg/m2 rituximab infusions at 1-week interval.

Personalized treatment:

restricted anti-CysR activity at inclusion : 6-month symptomatic antihypertensive and antiproteinuric treatment (KDIGO)
restricted anti-CysR activity after 6 months of symptomatic treatment with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 375 mg/m2 rituximab infusions at 1-week interval;
Anti-CTLD (C-type lectin domains ) 1/7 activity at inclusion or after 6 months with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 1g rituximab infusions at 2-week interval at month 0 and/or month 6.

ReferenceCitation: Simon N, Couroucé AM, Lemarrec N, Trépo C, Ducamp S. A twelve year natural history of hepatitis C virus infection in hemodialyzed patients. Kidney Int. 1994 Aug;46(2):504-11.

ReferenceCitation: Simon P, Ramee MP, Boulahrouz R, Stanescu C, Charasse C, Ang KS, Leonetti F, Cam G, Laruelle E, Autuly V, Rioux N. Epidemiologic data of primary glomerular diseases in western France. Kidney Int. 2004 Sep;66(3):905-8.

ReferenceCitation: Ponticelli C. Membranous nephropathy. J Nephrol. 2007 May-Jun;20(3):268-87. Review.

ReferenceCitation: Glassock RJ. The pathogenesis of idiopathic membranous nephropathy: a 50-year odyssey. Am J Kidney Dis. 2010 Jul;56(1):157-67. doi: 10.1053/j.ajkd.2010.01.008. Epub 2010 Apr 8. Review.

ReferenceCitation: Lassalle M, Ayav C, Frimat L, Jacquelinet C, Couchoud C; Au Nom du Registre REIN. The essential of 2012 results from the French Renal Epidemiology and Information Network (REIN) ESRD registry. Nephrol Ther. 2015 Apr;11(2):78-87. doi: 10.1016/j.nephro.2014.08.002. Epub 2014 Nov 1.

ReferenceCitation: Brglez V, Boyer-Suavet S, Zorzi K, Fernandez C, Fontas E, Esnault V, Seitz-Polski B. Personalized Medicine for PLA2R1-Related Membranous Nephropathy: A Multicenter Randomized Control Trial. Front Med (Lausanne). 2020 Aug 13;7:412. doi: 10.3389/fmed.2020.00412. eCollection 2020.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU Besançon
Le Kremlin Bicêtre
CHU D'amiens Hôpital Sud
CHU de Caen
Hôpital universitaire La Cavale Blanche
Hôpital de la maison blanche
CHU Carémeau
CHU Henri Mondor
Dr Barbara SEITZ-POLSKI
CHU de LYON NORD
CHU de Tours
CHU de Strasbourg
CHRU de LILLE
CHU de Toulouse
CHRU de Montpellier
Hôpital Necker
CHU Gabriel Montpied
AP-HM
CHU de NANTES


title: Study of Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma

acronym: AMPULLOMA

summary: A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone. At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established.In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Chu Saint Andre
Hopital Saint Joseph
Ch Saint Jean
CHU Hôpital de la Milétrie
Hcl Pierre Benite
Hcl Edouard Herriot
Le Kremlin Bicetre
Ch de Meaux
Chu La Croix Rousse
Chu Francois Mitterrand
CH
Chu La Pitie Salpetriere
Chu Cochin
Chu Claude Huriez
Chu Caremeau
Chu Estaing
Hopital Europeen Georges Pompidou
Polyclinique Bordeaux Nord Aquitaine
Ch Cote Basque
Hôpital Dupuytren
Chu Avicenne
Ch Saint Malo
Hopital de La Timone
Chd Vendee
Ch Annecy Genevois
Ch Bretagne Atlantique
Ch D'Abbeville
Ch Cornouaille
Clinique Champeau
Ch - Sud Francilien
Ch Nord Essonne
Chr Orleans
CH MACON
Hopitaux Civils de Colmar
Chu Hotel Dieu
CLINIQUE


title: Efficacy of Regorafenib as Maintenance Therapy in Non-adipocytic Soft Tissue Sarcoma Having Received First-line Doxorubicin-based Chemotherapy

summary: Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy.

lead_sponsor: Centre Oscar Lambret

location_facility: Institut régional du Cancer de Montpellier

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients

acronym: ONCOPRO

summary:
Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal.

In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma…) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development.

Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation.

Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'hôpital de la Croix-Rousse

location_facility: Service de Chirurgie de l'hôpital Lyon Sud

location_facility: Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'Hôpital E. Herriot

location_facility: Service de NEURO-ONCOLOGIE du Groupement Hospitalier EST

location_facility: Service d'Hématologie de l'Hôpital Lyon Sud

location_facility: Service de Dermatologie de l'hôpital Lyon Sud

location_facility: Service de Gynécologie du Groupement Hospitalier Est

location_facility: Service de Pneumologie du Groupement Hospitalier Est

location_facility: Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE du Centre Hospitalier Lyon Sud

location_facility: Service d'Oncologie médicale du Centre hospitalier Lyon Sud

location_facility: Service d'Urologie de l'hôpital Lyon Sud

location_facility: Service de Gynécologie de l'hôpital Lyon Sud

location_facility: Service de Pneumologie de l'Hôpital Lyon Sud

location_facility: Service de Pneumologie de l'hôpital de la Croix-Rousse

location_facility: Service de Gynécologie de l'hôpital de la Croix-Rousse

location_facility: Service d'Oto-Rhino-Laryngologie de l'Hôpital de la Croix-Rousse

location_facility: Service d'Urologie de l'Hôpital E. Herriot


title: Preemptive Therapy With Venetoclax for High Risk Chronic Lymphoid Leukemia Stage A Patients, a Phase II Trial of the FILO

summary: Open label, single arm, multicenter phase II trial.

ipd_sharing_description: eCRF

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: Centre Henri Becquerel - Service Hématologie Clinique


title: Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients

acronym: SOCRATE

summary:
The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed.

The co-primary endpoints are the following:

Six months survival rate
Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future

location_facility: Privee - Institut Du Cancer Avignon Provence


title: A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort

acronym: HAMA

summary: This registry aims to provide the first prospective, multicentric database of patients with malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity of current management and care pathway, to deepen our pathophysiological knowledges, to modernize the definition of this form of hypertension and its diagnostic criteria. The network that will emerge will finally lead to the opportunity of setting up therapeutic trials and establishing recommendations based on solid scientific evidence.

lead_sponsor: Centre Hospitalier de PAU

location_facility:
CHU de Pointe à Pitre
CH de Valenciennes
Hôpital Henri Mondor
CH de St Nazaire
hôpital de Haguenau
CHU Michallon
CHU de St Etienne
CH de Libourne
CH de PAU
Clinique sainte Clotilde
Hopital de la conception
Pôle Santé Sud
CH Métropole
CH de la côte Basque
CH Martigues
CHU de ROUEN
CHU de Strasbourg
CH d'Annecy
CHU de Rennes
CHU de Montellier
CHU - Hôpital Laennec
Clinique Vert Coteau
Hôpital Saint Joseph
Hôpital Européen Georges Pompidou
Hôpital Tenon
CHU - Hôpital St André
Fondation Adolphe de Rothschild
CHU de Clermont FERRAND
APHP Bichat
CHU de Toulouse Rangueil
CHU de Tours
CH de Chalon sur Saone
CHU de Poitiers
Avicenne APHP
CHRU de Lille
CH de Dinard


title: Multicenter Double Blind Randomized Phase II Trial of Olaparib vs Placebo as Maintenance Therapy in Platinum-sensitive Advanced Endometrial Carcinoma

acronym: UTOLA

summary: This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Institut de Cancérologie de Lorraine - Centre Alexis Vautrin

location_facility: Institut de Cancérologie du Gard - CHU de Nîmes

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Institut inter-régionaL de Cancérologie - Centre Jean Bernard - Clinique Victor Hugo

location_facility: Institut Daniel Hollard - GHM de Grenoble

location_facility: CHU Saint Etienne - Pôle de Cancérologie

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Institut Curie - Hopital Claudius Régaud


title: A Single-arm Phase II Multicenter Study of IDH2 (AG-221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome

summary: patients with MDS (Myelodysplastic Syndrome) and mutated IDH2 patients will be treated with AG221 (IDH2 inhibitor)

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Institut de cancérologie Lucien Neuwirth Saint priest en Jarez

location_facility: Institut Paoli Calmettes/Unité d'Hématologie 3

location_facility: Hôpital Archet 1/Service d'Hématologie Clinique

location_facility: CHU Côte de Nacre/Service d'Hématologie Clinique

location_facility: Centre Henri Becquerel/Département d'Hématologie

location_facility: CH d'Angers/Service des Maladies du sang

location_facility: CH Le Mans/Service d'hématologie Oncologie

location_facility: Hôpital Saint Louis - Service d'hématologie séniors

location_facility: CHU Nantes - Hôtel Dieu/Service d'Hématologie Clinique


title: National Observational Study of the Thoraflex™ Hybrid Vascular Prosthesis in the Replacement of the Aortic Arch and the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta

summary: The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation to morbidity-mortality, visceral malperfusions, neurological and renal complications, endoleak and evolution of the aortic thoracic stent over time.

ReferenceCitation: Arko FR, Lee WA, Hill BB, Olcott C 4th, Harris EJ, Dalman RL, Fogarty TJ, Zarins CK. Impact of endovascular repair on open aortic aneurysm surgical training. J Vasc Surg. 2001 Nov;34(5):885-91.

ReferenceCitation: Karck M, Chavan A, Hagl C, Friedrich H, Galanski M, Haverich A. The frozen elephant trunk technique: a new treatment for thoracic aortic aneurysms. J Thorac Cardiovasc Surg. 2003 Jun;125(6):1550-3.

ReferenceCitation: Usui A, Ueda Y, Watanabe T, Kawaguchi O, Ohara Y, Takagi Y, Tajima K, Nishikimi N, Ishiguchi T. Clinical results of implantation of an endovascular covered stent-graft via midsternotomy for distal aortic arch aneurysm. Cardiovasc Surg. 2000 Dec;8(7):545-9.

ReferenceCitation: Karck M, Kamiya H. Progress of the treatment for extended aortic aneurysms; is the frozen elephant trunk technique the next standard in the treatment of complex aortic disease including the arch? Eur J Cardiothorac Surg. 2008 Jun;33(6):1007-13. doi: 10.1016/j.ejcts.2008.02.030. Epub 2008 Apr 10. Review.

ReferenceCitation: Shrestha M, Pichlmaier M, Martens A, Hagl C, Khaladj N, Haverich A. Total aortic arch replacement with a novel four-branched frozen elephant trunk graft: first-in-man results. Eur J Cardiothorac Surg. 2013 Feb;43(2):406-10. doi: 10.1093/ejcts/ezs296. Epub 2012 May 31.

ReferenceCitation: Patel AY, Eagle KA, Vaishnava P. Acute type B aortic dissection: insights from the International Registry of Acute Aortic Dissection. Ann Cardiothorac Surg. 2014 Jul;3(4):368-74. doi: 10.3978/j.issn.2225-319X.2014.07.06. Review.

ReferenceCitation: Tsai TT, Trimarchi S, Nienaber CA. Acute aortic dissection: perspectives from the International Registry of Acute Aortic Dissection (IRAD). Eur J Vasc Endovasc Surg. 2009 Feb;37(2):149-59. doi: 10.1016/j.ejvs.2008.11.032. Epub 2008 Dec 20.

ReferenceCitation: Jakob H, Tsagakis K. International E-vita open registry. Ann Cardiothorac Surg. 2013 May;2(3):296-9. doi: 10.3978/j.issn.2225-319X.2013.03.10.

ReferenceCitation: Bortone AS, Schena S, D'Agostino D, Dialetto G, Paradiso V, Mannatrizio G, Fiore T, Cotrufo M, de Luca Tupputi Schinosa L. Immediate versus delayed endovascular treatment of post-traumatic aortic pseudoaneurysms and type B dissections: retrospective analysis and premises to the upcoming European trial. Circulation. 2002 Sep 24;106(12 Suppl 1):I234-40.

lead_sponsor: Vascutek Ltd.

location_facility: Hopitaux Universitaires - Nouvel Hopital Civil

location_facility: Hôpital Rangueil, Cardiothoracic Surgery Department

location_facility: Centre Hospitalier University (University Hospital centre)

location_facility: Groupe Hospitalier Pitié-Salpêtrière, Vascular Surgery Department

intervention_type: Device


title: A Phase II Pilot Study to Evaluate the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia With p53 Dysfunction. IDA53 Trial

summary:
Ibrutinib, a first-in-class Bruton Tyrosine kinase (BTK) inhibitor, has become an established treatment in relapsed/refractory chronic lymphocytic leukemia (CLL). However, despite a considerable improvement of Progression Free Survival (PFS) and Overall Survival (OS) in comparison with historical controls, the prognosis of patients with 17p deletion (del17p) remains a concern, as it is clearly much less favourable than that of patient without del17p. Again, TP53 mutations correlated to poorer prognostic in Relapsed/Refractory (R/R) CLL patients treated with ibrutinib (Brown JR et al,2018). Despite these therapeutic advances, the treatment of CLL with TP53 disruption thus remains a difficult issue that warrants evaluation of alternative treatment strategies, in particular the use of ibrutinib in combination with other agents. A body of evidence suggests that targeting the extracellular molecule CD38 might be an interesting option. CD38 is a transmembrane glycoprotein with multiple receptor and enzymatic functions. The interaction of CD38 with its ligand CD31 (also known as Platelet Endothelial Cell Adhesion Molecule (PECAM-1)) not only plays a role in the binding and the migration of leucocytes through the endothelial cells wall but also triggers the activation of intracellular pathways involved in the differentiation and activation of B cells. Previous results strongly suggest that CD38 favours the expansion of CLL clones not only directly by transducing a proliferation signal but also by directing them to anatomic sites where they find favourable conditions for proliferation and survival.

Daratumumab is a first-in-class human IgG1ĸ monoclonal antibody (mAb) that binds CD38-expressing malignant cells with high affinity. Daratumumab induces tumor cell death through multiple mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC), complement dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP) and induction of apoptosis (de Weers et al, 2011). Recent data show that daratumumab may also display an immunomodulatory effect through depletion of a subset of immunosuppressive CD38+ Tregs (Krejcik et al, 2016). Early-stage clinical trials found daratumumab to be safe and to display encouraging clinical activity as a single agent in relapsed/refractory multiple myeloma (MM) patients (Lockhorst et al 2016, Lonial et al, 2016). Overall response rate was 31%, with rapid (median 1 month) and durable responses in this heavily pretreated MM population. Interestingly, no patient discontinued the treatment because of drug-related adverse events. These results led to approval of daratumumab in relapsed/refractory MM in December 2015. The clinical efficacy of daratumumab along with its very favourable safety profile supports its investigation in other lymphoproliferative malignancies. In particular, the expression of CD38 in poor prognosis CLL and the key role of CD38 in CLL biology provide a basis for examining the potential of daratumumab in this disease.

In preclinical studies, (Matas-Céspedes et al, 2016; Manna et al, 2017) Daratumumab efficiently kills CLL cell lines and patient-derived CLL cells by ADCC and ADCP in vitro. Daratumumab modulates CLL-T reg levels and increase cytotoxic effector T cells.

Rationale for combining ibrutinib with daratumumab:

These data suggest that combining ibrutinib with daratumumab might have a synergistic or additive effect. Both drugs inhibit B cell receptor (BCR) signalling via two different converging pathways, i.e. BTK and CD38/ZAP70/ERK (Deaglio et al, 2007). In vitro, Manna et al have shown that daratumumab is able to modulate BCR signaling.

Interestingly, the ibrutinib /daratumumab combination significantly enhanced mitochondrial-mediated apoptosis bth in CD38 high and CD38 low CLL cells (Manna et al, 2017).

Altogether, this provides a rationale for evaluating the safety and efficacy of the association of daratumumab with ibrutinib in high-risk relapsed/refractory patients for whom the standard-of-care using ibrutinib as a single agent has demonstrated limitations in terms of long-term disease control.

Primary objective of the study: to determine the efficacy of a treatment combining daratumumab and ibrutinib in a poor risk population of relapsed CLL patients with TP53 dysfunction.

Secondary objectives of the study : to determine the safety profile of daratumumab in combination with ibrutinib in CLL patients.

Inclusion period: 24 months Treatment duration (ibrutinib + daratumumab): continuous, until disease progression or unacceptable toxicity.

Follow-up period: will begin once the subject discontinues study treatment, during 2 years.

location_facility: Hôpital Avicenne - Centre de Recherche Clinique

location_facility: Hôpital Saint-Eloi - Hématologie Clinique

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Robert Debré - Hématologie Clinique

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: CHLS - Lyon Pierre Bénite - Service Hématologie

location_facility: Hôpitaux de Brabois - Hématologie Adulte

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: CHU Bordeaux - Hôpital Haut-Lévèque - CFM Maladies du sang

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: Institut Paoli-Calmettes - Hématologie Clinique


title: Efficacy of Treatment Sequences in Patients With ALK and ROS-1 Positive Non-small Cell Lung Cancer Who Received Lorlatinib as Part of the French Expanded Access Program

acronym: LORLATU

summary: The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program.

ReferenceCitation: Baldacci S, Besse B, Avrillon V, Mennecier B, Mazieres J, Dubray-Longeras P, Cortot AB, Descourt R, Doubre H, Quantin X, Duruisseaux M, Monnet I, Moro-Sibilot D, Cadranel J, Clément-Duchêne C, Cousin S, Ricordel C, Merle P, Otto J, Schneider S, Langlais A, Morin F, Westeel V, Girard N. Lorlatinib for advanced anaplastic lymphoma kinase-positive non-small cell lung cancer: Results of the IFCT-1803 LORLATU cohort. Eur J Cancer. 2022 May;166:51-59. doi: 10.1016/j.ejca.2022.01.018. Epub 2022 Mar 9.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire


title: Multicenter Prospective Single Arm Phase II Study Evaluating Efficacy & Safety of Durvalumab With Carboplatin/Paclitaxel as First Line Treatment in Patients With Recurrent/Metastatic SCCHN Not Eligible to Standard Chemotherapy

acronym: FRAIL-IMMUNE

summary: The primary objective of the phase II trial is to determine the efficacy and safety of a combination of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy.

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin


status: Terminated

acronym: REGIRI

intervention_type: Combination Product

title: A Randomised Phase 2 Trial Assessing REGorafenib Combined With IRInotecan as Second-line Treatment in Patients With Metastatic Gastro-oesophageal Adenocarcinomas

ipd_sharing_description: Individual Participant Data will not be shared at an individual level, they will be part of the study database including all enrolled patients

location_facility: Institut de Cancérologie de l'Ouest-René Gauducheau

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Institut de Cancérologie de l'Ouest-Paul Papin

summary: Trial evaluating the efficacy of regorafenib combined with irinotecan compared to irinotecan alone in second-line treatment of patients with metastatic gastro-oesophageal adenocarcinomas.


title: CHARACTERISTICS OF ADULT PATIENTS TREATED WITH CRIZOTINIB FOR ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) WITH ALK GENE REARRANGEMENT OR ROS1 GENE REARRANGEMENT IN GENERAL HOSPITALS.

summary:
Descriptive Observational Study.

Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

lead_sponsor: Pfizer

location_facility: Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie

location_facility: Hopitaux Civils de Colmar - Hopital Louis Pasteur

location_facility: Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique

location_facility: Hopital Europeen - Service de Pneumologie

location_facility: Centre Hospitalier Chalon sur Saone William Morey

location_facility: Hopital Robert Ballanger, Service de Pneumologie

location_facility: Centre Hospitalier General Beziers, Service De Pneumologie

location_facility: Centre Hospitalier Metropole de Savoie-Site de Chambery

location_facility: Centre Hospitalier de l'Agglomeration de Nevers

location_facility: Centre Hospitalier de Villefranche sur Saone - BP80436

location_facility: Centre Hospitalier des Deux Vallees - Longjumeau BP 125

location_facility: Centre Hospitalier Départemental Les Oudairies


title: A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration

acronym: GAVAPROSEC

summary: The primary objective of the study is to demonstrate the superiority of an "early tips" strategy over standard treatment by glue obliteration (G0) in preventing bleeding recurrence or death at one year after a non GOV1 gastric variceal bleeding in cirrhotic patients initially treated by GO.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
University Hospital of Nice
St Antoine Hospital
CHU Lyon
University Hospital of Lille
University Hospital of Nantes
University Hospital of Angers
Paul Brousse Hospital
University Hospital of Rennes
Univerity Hospital of Bondy
University Hospital of Tours
University Hospital of Toulouse
University Hospital of Caen
University Hospital of Marseille
University Hospital of Besançon
CHRU Brest
University Hospital of Montpellier
CHU Amiens
University Hospital of Bordeaux
University Hospital of Dijon
Pitié Salpétrière Hospital


title: Durvalumab Plus Tremelimumab Combination Immunotherapy With or Without Weekly Paclitaxel in Patients With Advanced Biliary Tract Carcinoma (BTC) After Failure of Platinum-based Chemotherapy: a Randomized Non-comparative Two-arm Phase II Study

acronym: IMMUNO-BIL

summary:
IMMUNO-BIL is a non-comparative randomized 1:1 phase II study. This study will assess the efficacy and safety of the combination of durvalumab plus tremelimumab with or without weekly paclitaxel in patients with advanced BTC after failure of platinum-based chemotherapy.

On the 25th June 2019, the maximum DLT event number was reached (6/10) in the durvalumab plus tremelimumab combination with paclitaxel Arm (Arm B). According to the Pocock boundary described in the protocol, GERCOR has updated the study to discontinue enrollment in Arm B (durvalumab plus tremelimumab with paclitaxel) . No safety concerns were raised by the IDMC in Arm A. Consequently, the study will resume with Arm A (durvalumab plus tremelimumab) only, without randomization.

Discontinuation of ARM B(June 2019): Durvalumab plus tremelimumab plus paclitaxel

One cycle equals 4 weeks (D1=D28); Durvalumab: 1,500 mg by IV infusion on D1, until progression or unacceptable toxicity or withdrawal of consent.

Tremelimumab: 75 mg by IV infusion on D1 for the first 4 cycles. Paclitaxel: 80 mg/m2, every week for 3 weeks (D1-D8-D15), by IV infusion, until progression or unacceptable toxicity or withdrawal of consent (at least 6 cycles, at the discretion of the investigator).

December 2020: Tremelimumab dosage modification based on the results of the Study 22 study (Kelley RK, et al. ASCO20 Virtual Scientific Program 2020) showing increased efficacy (response rate and progression-free survival) without safety concerns with one dose of tremelimumab 300 mg (cycle 1) instead of four doses of 75 mg (cycle 1 to cycle 4) in combination with durvalumab 1,500 mg Q4W in hepatocellular carcinoma. Following these results, we have changed the tremelimumab 75 mg x 4 schedule for the 300 mg x 1 schedule. The inclusion of 106 additional patients will be required to adequately evaluate the efficacy of this administration schedule.

ARM A : Durvalumab plus tremelimumab ( patients included before 31/12/2020) One cycle equals 4 weeks (D1=D28);

Durvalumab: 1,500 mg by IV infusion on D1, until progression or unacceptable toxicity or withdrawal of consent.

Tremelimumab: 75 mg by IV infusion on D1 for the first 4 cycles.

ReferenceCitation: Boilève A, Hilmi M, Gougis P, Cohen R, Rousseau B, Blanc JF, Ben Abdelghani M, Castanié H, Dahan L, Tougeron D, Metges JP, Tournigand C, Garcia-Larnicol ML, Vernerey D, Turpin A, Neuzillet C. Triplet combination of durvalumab, tremelimumab, and paclitaxel in biliary tract carcinomas: Safety run-in results of the randomized IMMUNOBIL PRODIGE 57 phase II trial. Eur J Cancer. 2021 Jan;143:55-63. doi: 10.1016/j.ejca.2020.10.027. Epub 2020 Dec 3.

location_facility:
CHU Robert Debré
Centre Georges François Leclerc
Centre Paul Strauss
CHU Henri Mondor
Hôpital Privé Jean Mermoz
Hôpital Cochin
Hôpital la Timone
Institut Hospitalier franco-Britannique
Institut Mutualiste Montsouris
CHRU Jean Minjoz
Hôpital Haut Lévêque
Centre Léon Bérard
Hôpital Beaujon
Polyclinique Bordeaux Nord Aquitaine
CHRU Lille
Hôpital Saint Antoine
CHU Poitiers
Institut Andrée Dutreix
Institut Curie
Insitut Gustave Roussy
CHU Morvan
CHPSO Site de Creil
Hôpital Prive du confluent SAS
Hôpital Duchenne
CHI Poissy Saint Germain
Hôpital Saint Eloi
Centre Eugène Marquis
CHU Dijon


title: Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression

acronym: ACOUSTIM

summary: Treatment resistant depression (TRD) is a frequent, debilitating condition mostly treated by antidepressants. Repeated magnetic transcranial stimulation (rTMS) has proven adjuvant efficacy in TRD in the acute phase of treatment with a very good tolerance and acceptability. Maintenance rTMS (mTMS) is a strategy consisting in adding regular single TMS sessions after response to an acute course in order to keep the benefit of initial treatment over several month or years. Demonstrating that rTMS is efficient to improve long-term prognosis and decrease economic burden would have a tremendous impact in clinical practice in psychiatry. Thus the investigator's aim is to analyze the long term impact of mTMS treatment on costs, but also quality of life and clinical issues.

primary_purpose: Other

ReferenceCitation: Bulteau S, Laurin A, Volteau C, Dert C, Lagalice L, Schirr-Bonnans S, Bukowski N, Guitteny M, Simons L, Cabelguen C, Pichot A, Tessier F, Bonnin A, Lepage A; ACOUSTIM Investigators Group; HUGOPSY Network, Vanelle JM, Sauvaget A, Riche VP. Cost-utility analysis of curative and maintenance repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant unipolar depression: a randomized controlled trial protocol. Trials. 2020 Apr 5;21(1):312. doi: 10.1186/s13063-020-04255-9.

lead_sponsor: Nantes University Hospital

location_facility: Centre hospitalier Guillaume Regnier Rennes


title: Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial

acronym: QUALIREHAB

summary: The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.

ReferenceCitation: Amedro P, Gavotto A, Legendre A, Lavastre K, Bredy C, De La Villeon G, Matecki S, Vandenberghe D, Ladeveze M, Bajolle F, Bosser G, Bouvaist H, Brosset P, Cohen L, Cohen S, Corone S, Dauphin C, Dulac Y, Hascoet S, Iriart X, Ladouceur M, Mace L, Neagu OA, Ovaert C, Picot MC, Poirette L, Sidney F, Soullier C, Thambo JB, Combes N, Bonnet D, Guillaumont S. Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: The QUALI-REHAB study rationale, design and methods. Int J Cardiol. 2019 May 15;283:112-118. doi: 10.1016/j.ijcard.2018.12.050. Epub 2018 Dec 20.

lead_sponsor: University Hospital, Montpellier

location_facility: Haut Lévêques - Bordeaux University Hospital

location_facility: Gabriel Montpied Hospital- Clermont Ferrand University Hospital

location_facility: La Timone- Public Assistance - Marseille hospitals

location_facility: Arnaud de Villeneuve - University Hospital

location_facility: Barbois Hospital - Nancy University Hospital

location_facility: Children and Mother Hospital - Limoges University Hospital

location_facility: La Miletrie -Poitier University Hospital

location_facility: Children Hospital - Toulouse University Hospital


title: Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum

acronym: EVA (ECE)

summary: Women report inappropriate health professional behaviour towards them during pregnancy or childbirth on social networks. However, to date, no data are available to estimate the number of women concerned. These data are necessary to characterize these behaviours to get out of this polemic and build a reflection on the improvement of the patient relationship and the emotional security of women.

location_facility: Polyclinique Lyon Nord Service Maternité (NATECIA)

location_facility: Centre Hospitalier de Sainte Foy les Lyon

location_facility: Réseau AURORE, service de gynécologie Obstétrique, Hôpital de la Croix-Rousse

location_facility: CH de BOURG EN BRESSE - Pôle Mère Enfant

location_facility: Hôpital Privé Drôme Ardèche Clinique Pasteur

location_facility: Centre Hospitalier de Villefranche Sur Saône Hôpital Nord-Ouest


acronym: EFFICACI

title: EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical Trial

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Assistance Publique des Hôpitaux de Paris - Hôpital Henri Mondor

location_facility: Assistance Publique des Hôpitaux de Paris - Hôpital Beaujon

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire d'Amiens-Picardie

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Assistance Publique des Hôpitaux de Paris - Hôpital Saint-Louis

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Strasbourg

summary:
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that results from immune dysregulation. Arguably, the development of Tumor Necrosis Factor (TNF) antagonists (including infliximab, adalimumab and golimumab) revolutionized the management of immune-mediated chronic diseases in the past two decades.

However, about one third of patients will not respond to a first anti-TNF treatment and 10% to 30% will loose response to anti-TNF during the follow-up.

Historically, a switch between anti-TNF was performed to recapture remission and response to anti-TNF. Recently, a new biologic therapy blocking another target has been approved and is now reimbursed during ulcerative colitis, namely vedolizumab. Vedolizumab is an anti-integrin agent avoiding the recruitment of lymphocytes specifically in inflamed gut tissue.

Emerging data suggest that a switch of therapeutic class (meaning a change of biologic target with Non-TNF-targeted biologic) in case of clinical failure or insufficient response to anti-TNF may be the best choice. This idea of a switch out of the anti-TNF class is also supported by data on drug monitoring that may help physician decision making in case of loss of response. However, no trial is currently available and ongoing to assess the best therapeutic strategy. The aim of the proposed study is to assess the best biological based strategy in patient losing response to a first subcutaneous anti-TNF (golimumab and/or adalimumab).


title: Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma

acronym: StrateGlio

summary: Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d'Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.

location_facility:
CHU Grenoble Alpes
Institut Cancérologie Loire
ICO Centre Paul Papin
Centre Georges François Leclerc
CHU La Timone
ICM Val d'Aurelle
CHRU Nancy
Centre Jean Perrin
CHU de Nice - Hôpital de Cimiez
APHP La Pitié Salpêtrière
Centre Paul Strauss
Centre Hospitalier d'Amiens
CHRU Tours
Centre Léon Bérard
ICO Centre René Gauducheau
CHU de Limoges
CH René Dubos
Centre François Baclesse
Hôpitaux Civils de Colmar


title: A Multicentric Randomized Phase II/III Evaluating TSR-042 (Anti-PD-1 mAb) in Combination With Niraparib (Parpi) Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy

acronym: ROCSAN

summary: Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) < 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is <20%, progression-free survival (PFS) <4 months, and OS <1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.

ipd_sharing_description: No sharing plan

location_facility: Hopital Milétrie - Centre Hospitalier Universitaire Poitiers

location_facility: Institut Régional du Cancer de Montpellier (ICM Val d'Aurelle)

location_facility: Groupe Hospitalier des Diaconesses Croix Saint-Simon

location_facility: Centre Régional de Lutte contre le cancer - Institut Bergonié


title: Multicentre, Randomised, Phase 2 Trial of Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (Metastatic Osteosarcoma at Diagnosis or Localised Disease With Poor Histological Response)

lead_sponsor: UNICANCER

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

ReferenceCitation: Brard C, Piperno-Neumann S, Delaye J, Brugières L, Hampson LV, Le Teuff G, Le Deley MC, Gaspar N. Sarcome-13/OS2016 trial protocol: a multicentre, randomised, open-label, phase II trial of mifamurtide combined with postoperative chemotherapy for patients with newly diagnosed high-risk osteosarcoma. BMJ Open. 2019 May 19;9(5):e025877. doi: 10.1136/bmjopen-2018-025877.

ipd_sharing_description: Individual participant data will not be shared at an individual level, they will be part of the study database including all enrolled patients.

location_facility: Institut de Cancérologie de Lorraine - Service d'oncologie médicale

location_facility: Hôpital Clocheville - Hématologie et oncologie pédiatrique

location_facility: CHU de Grenoble - Service d'oncologie hématologie pédiatrique

location_facility: CHU de Caen - Service d'oncologie hématologie pédiatrique

location_facility: Institut de Cancérologie de l'Ouest (Site René Gauducheau) - Service d'oncologie médicale

location_facility: CHU de Nice - Service d'oncologie hématologie pédiatrique

location_facility: Institut Gustave Roussy - Service d'oncologie médicale

location_facility: Institut régional du Cancer de Montpellier - Service d'oncologie médicale

location_facility: Institut Curie - Service d'oncologie pédiatrique

location_facility: CHU de Nantes - Service d'oncologie hématologie pédiatrique

location_facility: CHU Bretonneau - Service d'oncologie médicale

location_facility: Institut Bergonié - Service d'oncologie médicale

location_facility: Centre Léon Bérard - Service d'oncologie médicale

location_facility: Hôpital de la Timone - service d'oncologie médicale

location_facility: CHRU de Nancy - Onco-hématologie pédiatrique

location_facility: Institut Claudius Regaud - service d'oncologie médicale

location_facility: CHU Amiens-Picardie - Service d'oncologie hématologie pédiatrique

location_facility: CHU d'Angers - Service d'oncologie pédiatrique

location_facility: Centre Eugène Marquis - Service d'oncologie médicale

location_facility: Hôpital Armand Trousseau - Service d'hématologie et d'oncologie pédiatrique

location_facility: Hôpital Hautepierre - Onco-hématologie pédiatrique

location_facility: CHU Toulouse - Hôpital des Enfants - Service d'Hémato-Immuno-Oncologie

location_facility: Hôpital de la Timone - Service d'oncologie pédiatrique

location_facility: Hôpital de Hautepierre - Onco-hématologie adulte

location_facility: Hôpital Charles Nicolle - Hémato-Immuno-Oncologie Pédiatrique

location_facility: Institut Gustave Roussy - Service de cancérologie de l'enfant et de l'adolescent

location_facility: CHU Arnaud de Villeneuve - Onco-hématologie pédiatrique

location_facility: Institut Curie - Service d'oncologie médicale

location_facility: Centre Oscar Lambret - Unité d'onco-pédiatrie

summary: Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response).


title: Impact of 2 Transfusion Strategies on the Quality of Life of Multi-transfused Patients With Low Risk Myelodysplastic Syndrome: Multicenter Randomized Trial Comparing a Liberal vs. Restrictive Transfusion Regimen

acronym: SMD-transfu

summary:
Myelodysplastic syndromes (MDS) are heterogeneous malignant bone marrow disorders characterized by ineffective haematopoiesis, peripheral blood cytopenias and variable risk of leukaemia transformation.

Anemia is the most common manifestation of bone marrow failure in MDS. After failure with first-line treatment by Erythropoietin, patients survive in average 5 years under long term blood transfusion. Modalities of blood transfusion are not clearly defined.

Then, the objective of this randomized comparative multicentric study is to compare two modalities of threshold for transfusion:

Restrictive group: Hb < 80g/L and Hb maintain between 80 and 100g/L
Liberal group: Hb < 100g/L and Hb maintain between 100 and 120g/L

lead_sponsor: Lille Catholic University

location_facility:
Saint-Louis Hospital, APHP
Clermont-Ferrand CHU
Henri Duffaut CH
Bordeaux CHU
Besançon CHU
Le Mans CH
Grenoble CHU
Lens CH
Pontchaillou Hospital
Arras CH
Cote de Nacre CHU
Meaux CH
Archet 1 Hospital
Limoges CHRU
Abbeville CH
Dunkerque CH
St-Vincent Hospital
Amiens CHU
Roubaix CH


title: Evaluation of Perioperative Eltrombopag for the Management of Elective Surgery and Invasive Acts in Patients With Inherited Thrombocytopenia

acronym: ELPOT

summary: The objective of the study is to estimate the response to eltrombopag based on platelet count increase above a safety level of 80 G/L and lack of requirement for pre-, per- and post-operative administration of platelet concentrates (PC) for performing elective invasive acts at mild or high bleeding risk,in selected patients with inherited thrombocytopenia (IT).

ReferenceCitation: Pecci A, Gresele P, Klersy C, Savoia A, Noris P, Fierro T, Bozzi V, Mezzasoma AM, Melazzini F, Balduini CL. Eltrombopag for the treatment of the inherited thrombocytopenia deriving from MYH9 mutations. Blood. 2010 Dec 23;116(26):5832-7. doi: 10.1182/blood-2010-08-304725. Epub 2010 Sep 15.

ReferenceCitation: Pecci A. Pathogenesis and management of inherited thrombocytopenias: rationale for the use of thrombopoietin-receptor agonists. Int J Hematol. 2013 Jul;98(1):34-47. doi: 10.1007/s12185-013-1351-7. Epub 2013 May 1. Review.

ReferenceCitation: Pecci A, Barozzi S, d'Amico S, Balduini CL. Short-term eltrombopag for surgical preparation of a patient with inherited thrombocytopenia deriving from MYH9 mutation. Thromb Haemost. 2012 Jun;107(6):1188-9. doi: 10.1160/TH12-01-0005. Epub 2012 Mar 8.

ReferenceCitation: Gerrits AJ, Leven EA, Frelinger AL 3rd, Brigstocke SL, Berny-Lang MA, Mitchell WB, Revel-Vilk S, Tamary H, Carmichael SL, Barnard MR, Michelson AD, Bussel JB. Effects of eltrombopag on platelet count and platelet activation in Wiskott-Aldrich syndrome/X-linked thrombocytopenia. Blood. 2015 Sep 10;126(11):1367-78. doi: 10.1182/blood-2014-09-602573. Epub 2015 Jul 29.

ReferenceCitation: Favier R, Feriel J, Favier M, Denoyelle F, Martignetti JA. First successful use of eltrombopag before surgery in a child with MYH9-related thrombocytopenia. Pediatrics. 2013 Sep;132(3):e793-5. doi: 10.1542/peds.2012-3807. Epub 2013 Aug 12.

ReferenceCitation: Fiore M, Saut N, Alessi MC, Viallard JF. Successful use of eltrombopag for surgical preparation in a patient with ANKRD26-related thrombocytopenia. Platelets. 2016 Dec;27(8):828-829. Epub 2016 Jun 8.

ReferenceCitation: Zhang J, Liang Y, Ai Y, Xie J, Li Y, Zheng W. Thrombopoietin-receptor agonists for children with immune thrombocytopenia: a systematic review. Expert Opin Pharmacother. 2017 Oct;18(15):1543-1551. doi: 10.1080/14656566.2017.1373091. Epub 2017 Sep 4. Review.

lead_sponsor: University Hospital, Toulouse

location_facility:
Strasbourg Hospital
university hospital Toulouse
Nantes Hospital
Poitiers Hospital
Rennes Hospital
Hospices Civils Lyon
Hopital Europeen G Pompidou
Dijon Hospital
Montpellier Hospital
Caen Hospital
Marseille Hospital
Robert Debré Hospital
Cochin Hospital
Angers Hospital
Reims Hospital
Tours Hospital
Bensancon Hospital
Nancy Hospital
Rouen Hospital
Necker Hospital
Bordeaux Hospital
Kremlin Bicetre Hospital
Clermont-Ferrand Hospital
Lille Hospital
Trousseau Hospital


title: Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma

summary:
Sentinel lymph node dissection (SLND) after NAC, aimed to reduce the rate of unnecessary axillary lymphadenectomy, is not a standard of care in case of patient with previously involved node before NAC because of a too high false negative rate (FNR).

Clinical consequences of FNR of SLND after NAC are currently unknown. Consequently, contrary to adjuvant setting, a risk of SLND false negative case after NAC is not acceptable.

GANEA3 aims to evaluate the results of an innovative multiparametric strategy combining (1) an identification before chemotherapy of a lymph node involvement using a metal clip and then its analysis after treatment, (2) the analysis of sentinel lymph node (SLN) after NAC, and (3) analysis of biological parameters of breast tumor before and after NAC, to predict axillary status after NAC. This will identify patients with initial lymph node involvement who could benefit from SLN after NAC without additional axillary dissection with a very low FNR (≤1%).

The most "pathological" metastatic lymph node will be identified with a metal clip under ultrasound. They will then receive a NAC before breast and axillary surgery. An assessment of the NAC response at the breast and axillary will be performed by imagery. Then, all patients undergo the resection of the tagged axillary node with the metal clip, SLN detection and biopsy and a complementary axillary lymphadenectomy.

ReferenceCitation: Ditsch N, Rubio IT, Gasparri ML, de Boniface J, Kuehn T. Breast and axillary surgery in malignant breast disease: a review focused on literature of 2018 and 2019. Curr Opin Obstet Gynecol. 2020 Feb;32(1):91-99. doi: 10.1097/GCO.0000000000000593. Review.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Institut Bergonié
APHP - Pitié Salpétrière
Hôpital St JOSEPH
Céline RENAUDEAU
Institut Paoli Calmettes
Centre Jean Perrin
Institut de Cancérlogie de Lorraine
CHU Brest
Centre Léon Bérard
Oscar Lambret
CURIE
ICO - Site ANGERS
Centre Jean Godinot
Centre Georges Francoise Leclerc
Institut de Cancérologie de Montpellier
CHP St GREGOIRE
Anne-Sophie Georges BATS
IUCT-O


title: Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS

acronym: BFR-ESS

summary: The primary objective is to compare the progression-free survival (PFS) between aromatase inhibitors interruption and aromatase inhibitors maintenance strategies in patients with a locally advanced or metastatic Low Grade Endometrial Stromal Sarcoma (LGESS).

lead_sponsor: Centre Leon Berard

location_facility: Groupe Hospitalier Diaconesses - Crois Saint Simon

location_facility: Institut de Cancérologie Lucien Neuwirth


title: A Phase II Study of Dexamethasone Added to Induction and Post-remission Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

summary: Recent preclinical and clinical data strongly suggested that dexamethasone could improve the activity of intensive chemotherapy in AML. In this study, the FILO study group will assess the impact of adding dexamethasone to both induction and consolidation therapy in older AML patients with intermediate or favorable risk.

lead_sponsor: French Innovative Leukemia Organisation

location_facility: Institut Paoli-Calmettes - Hématologie 2

location_facility: Hôpital Saint-Eloi - Hématologie Clinique

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie

location_facility: Hôpital Haut Levêque- CFM -Hématologie Clinique Et Thérapie Cellulaire

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: CHU Reims - Hôpital Robert Debré - Hématologie Clinique

location_facility: CHU Brest - Hôpital Morvan - Hématologie Clinique

location_facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

location_facility: CHU Bretonneau - Centre Henri Kaplan - Hématologie et Thérapie Cellulaire


title: Impact of a New Sequential Approach on Antimicrobial Use in Young Children With Fever Without Source in Emergency Department

acronym: DIAFEVER

summary: Because a newly available point-of-care test may have real interest especially for children in the Emergency Department (ED) setting, by limiting painful and stressful venipunctures and decreasing the length of stay in the ED, the investigators hypothesize that integrating this new capillary Procalcitonin (PCT) rapid test in the DIAFEVER CPR (Clinical Prediction Rules) could represent a highly valuable diagnostic tool to identify a group with low Invasive Bacterial Infection (IBI) risk and could limit unnecessary exams and antibiotic prescriptions. The aim of this present study is to demonstrate the impact of this new PCT rapid-test-based CPR on antibiotic prescription rate in young children with Fever Without Source (FWS) presenting to the ED and on morbidity and mortality

ReferenceCitation: Hubert G, Launay E, Feildel Fournial C, Chauvire-Drouard A, Lorton F, Tavernier E, Giraudeau B, Gras Le Guen C. Assessment of the impact of a new sequential approach to antimicrobial use in young febrile children in the emergency department (DIAFEVERCHILD): a French prospective multicentric controlled, open, cluster-randomised, parallel-group study protocol. BMJ Open. 2020 Aug 13;10(8):e034828. doi: 10.1136/bmjopen-2019-034828.

location_country: France Switzerland

location_facility:
University Hospital
Centre Hospitalier Intercommunal
Hopital Louis Mourier
Regional University Hospital
Saint Antoine Saint Vincent Hospital
AP-HP Robert Debré
Chu Saint Etienne
Southern Bretagne Hospital
CHU
AP-HP Antoine Béclère
CHD Vendée
Hopital des Enfants
Saint Brieuc Hospital
AP-HP Necker-Enfants Malades
Hospices civils de Lyon


acronym: PRO-MSACTIVE

title: An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Manchon E, Laplaud D, Vukusic S, Labauge P, Moreau T, Kobelt G, Grouin JM, Lotz M, Pau D, Christine LF. Efficacy, safety and patient reported outcomes in patients with active relapsing multiple sclerosis treated with ocrelizumab: Final results from the PRO-MSACTIVE study. Mult Scler Relat Disord. 2022 Aug 13;68:104109. doi: 10.1016/j.msard.2022.104109. [Epub ahead of print] Review.

location_facility: Hôpital Charles Nicolle; Service de Neurologie

location_facility: Hopital Civil de Strasbourg; Service de Neurologie

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: CHU Brest Hopital La Cavale Blanche; Neurologie

location_facility: Groupe Hospitalier Paris Saint Joseph; Service de Neurologie et Neurovasculaire

location_facility: Centre hospitalier Annecy Genevois Site St Julien; Neurologie

location_facility: Hopital européen de Marseille; Neurologie

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: Hôpital General - Service de neurologie; Service de neurologie

location_facility: CHU Saint Etienne - Hôpital Nord; Neurologie

location_facility: Fondation Hopital Saint Joseph; Neurologie

location_facility: HIA de Toulon hôpital militaire; Neurologie

location_facility: Centre hospitalier de Libourne Hopital Robert Boulin; Neurologie

location_facility: Centre hospitalier Andre Mignot; Neurologie

location_facility: Centre hospitalier Guy Chatiliez de Tourcoing; Neurologie

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Centre hospitalier de Valence; Neurologie

location_facility: Centre Hospitalier de Cornouaille; Neurologie

location_facility: Fondation Rothschild; Service de Neurologie

location_facility: Centre hospitalier de Montlucon; Neurologie

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Centre hospitalier de Mulhouse Hopital Emile Muller; Neurologie

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: CHU Angers, Batiement Larrey 2, Neurologie

summary: This national, open-label study is designed to give complementary efficacy, safety and patient reported outcomes (PROs) data in participants with active relapsing forms of MS. Participants will receive a maximum of 2 treatment cycles of ocrelizumab infusions: an initial dose of two 300 milligram (mg) infusions separated by 14 days followed by one single infusion of 600 mg ocrelizumab 24 weeks after the first infusion. Disease activity is determined by clinical relapses and/or Magnetic Resonance Imaging (MRI) activity.