Beaumont-de-lomagne, France
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/ASpan
157 weeksSponsor
Nantes University HospitalSaint-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/ASpan
362 weeksSponsor
Federation Francophone de Cancerologie DigestiveSaint-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
2Span
263 weeksSponsor
UNICANCERSaint-Malo
Recruiting
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
2Span
248 weeksSponsor
GERCOR - Multidisciplinary Oncology Cooperative GroupSaint-Malo
Recruiting
Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study
Phase
N/ASpan
79 weeksSponsor
Nantes University HospitalSaint-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/ASpan
133 weeksSponsor
Institut BergoniéSaint-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
3Span
210 weeksSponsor
University Hospital, ToursSaint-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
3Span
291 weeksSponsor
AstraZenecaSaint-Malo
Recruiting
Covid-19 Pediatric Observatory
Phase
N/ASpan
221 weeksSponsor
Centre Hospitalier Intercommunal CreteilSaint-Malo
Recruiting