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  • Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU

    Phase

    N/A

    Span

    157 weeks

    Sponsor

    Nantes University Hospital

    Saint-Malo

    Recruiting

  • A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers

    The aim is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences.

    Phase

    N/A

    Span

    362 weeks

    Sponsor

    Federation Francophone de Cancerologie Digestive

    Saint-Malo

    Recruiting

  • Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme

    Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to [U] in DPD-deficient patients with gastrointestinal cancer.

    Phase

    2

    Span

    263 weeks

    Sponsor

    UNICANCER

    Saint-Malo

    Recruiting

  • Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer

    Phase

    2

    Span

    188 weeks

    Sponsor

    UNICANCER

    Saint-Malo

    Recruiting

  • First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer

    The primary objective of the study is to assess the objective response rate (ORR) at 4 months (based on Response Evaluation Criteria in Solid Tumor [RECIST] criteria) of patients with PD-L1 CPS ≥ 5 advanced gastric cancer treated by EXL01 plus nivolumab and FOLFOX as first-line treatment. With a randomization ratio of 2:1 it will be necessary to randomize 40 patients in the control arm, 80 patients in the experimental arm and so a total of 120 evaluable patients in the study. Randomization will be stratified by PD-L1 expression level, center, and prior gastrectomy. In the experimental arm, the primary analysis will be on modified intent-to-treat (mITT) population. Confirmative analysis will be conducted firstly in the ITT population and secondly, in the Per Protocol (PP). Analyses of safety will be conducted in safety population. The Kaplan-Meier method will be used to estimate time to event endpoints and described using the median and event-free rates over time with CI.

    Phase

    2

    Span

    248 weeks

    Sponsor

    GERCOR - Multidisciplinary Oncology Cooperative Group

    Saint-Malo

    Recruiting

  • Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study

    Phase

    N/A

    Span

    79 weeks

    Sponsor

    Nantes University Hospital

    Saint-Malo

    Recruiting

  • Streamlined Geriatric and Oncological Evaluation Based On IC Technology

    This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months. A total of 10 patients by step are to be included in each center; these 10 patients must be regularly included along the 2-month period of each step. If 10 patients are already included before the end of the 2 months' step period, the center has to stop the inclusions till the beginning of the subsequent step. If a center, near to the end of a step, is far from reaching of the 10 patients' inclusion, it must increase the speed of its inclusions to be as close as possible of 10 patients included at the end of the step. In each center, patient sample has to be representative of type of cancer managed in the center, along the trial duration. The repartition of cancer types must be homogeneous along the steps and during the trial duration. All participating investigating sites will have study collaborators in charge of organizing intervention implementation and data collection. The intervention will be prepared prior to the start of the trial, so that each investigating site can implement it as defined by the randomisation. Each center engaged to participate needs to participate till the end of the trial. A center commitment to participate will be requested before each center involvement to avoid center withdrawal after the start of the trial. Quantitative data regarding the myPatientSpace adapted for GERONTE app usage will be collected at each step and in each cluster by study collaborators, from the beginning of GERONTE system implementation. Care outcome data (Quality of life, anxiety, autonomy, additional hospitalisation, mortality...) will be collected by local referents at 3, 6, 9 and 12 months after inclusion in GERONTE. The data necessary to calculate the real cost of the intervention, of its implementation and of resource use data of patient management will be continuously collected during follow-up. GERONTE patient-centered system implementation and usage will be collected by the local referents in each center. Qualitative analysis will be performed in each center at GERONTE system implementation and during follow-up.

    Phase

    N/A

    Span

    133 weeks

    Sponsor

    Institut Bergonié

    Saint-Malo

    Recruiting

  • Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease

    Phase

    3

    Span

    210 weeks

    Sponsor

    University Hospital, Tours

    Saint-Malo

    Recruiting

  • A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

    Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment. Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig + chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed until disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

    Phase

    3

    Span

    291 weeks

    Sponsor

    AstraZeneca

    Saint-Malo

    Recruiting

  • Covid-19 Pediatric Observatory

    Phase

    N/A

    Span

    221 weeks

    Sponsor

    Centre Hospitalier Intercommunal Creteil

    Saint-Malo

    Recruiting

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