Informations générales (source: ClinicalTrials.gov)
Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study (POP-UP)
Interventional
N/A
GERCOR - Multidisciplinary Oncology Cooperative Group (Voir sur ClinicalTrials)
août 2024
mars 2027
26 juillet 2024
This is a multicenter, two-cohort, open-label, single-arm feasibility study. The primary
objective is to assess the feasibility of the 8-week trimodal prehabilitation program
alongside perioperative triplet chemotherapy in eligible patients with localized
pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) .
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:26 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Lille - Lille - France | PIESSEN Guillaume, MD | Contact (sur clinicalTrials) | |||
| Institut Curie - Saint-Cloud - France | Cindy NEUZILLET, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de L'Ouest Rene Gauducheau - Saint-Herblain - France | Damien VANSTEENE, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - Marseille - France | Brice CHANEZ, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Signed and dated patient informed consent form (ICF) and willingness to comply with
all study procedures and availability for the study duration,
- Histologically or cytologically localized PDAC or OGC validated by the
multidisciplinary team,
- Indication to a preoperative treatment withtriplet chemotherapy for ≥ 4 cycles (8
weeks), Note: Patient treated for PDAC, first cycle without oxaliplatin is
authorized.
- Age > 18 years; If aged ≥ 75 years: G8 score must be ≥ 14 and if < 14 validation of
oncogeriatric specialist,
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 at inclusion
visit (first prehabilitation hospital-day),
- No prior treatment for PDAC or OGC before screening visit,
- At least one measurable or evaluable lesion as assessed by Computerized Tomography
scan or Magnetic resonance imaging according to RECIST 1.1 and feasibility of
repeated radiological assessments on baseline imaging before starting chemotherapy,
- Adequate hematologic and end-organ function allowing the triple combination
chemotherapy protocol,
- Registration in a national health care system (PUMa - Protection Universelle Maladie
included).
- Signed and dated patient informed consent form (ICF) and willingness to comply with
all study procedures and availability for the study duration,
- Histologically or cytologically localized PDAC or OGC validated by the
multidisciplinary team,
- Indication to a preoperative treatment withtriplet chemotherapy for ≥ 4 cycles (8
weeks), Note: Patient treated for PDAC, first cycle without oxaliplatin is
authorized.
- Age > 18 years; If aged ≥ 75 years: G8 score must be ≥ 14 and if < 14 validation of
oncogeriatric specialist,
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 at inclusion
visit (first prehabilitation hospital-day),
- No prior treatment for PDAC or OGC before screening visit,
- At least one measurable or evaluable lesion as assessed by Computerized Tomography
scan or Magnetic resonance imaging according to RECIST 1.1 and feasibility of
repeated radiological assessments on baseline imaging before starting chemotherapy,
- Adequate hematologic and end-organ function allowing the triple combination
chemotherapy protocol,
- Registration in a national health care system (PUMa - Protection Universelle Maladie
included).
- Evidence of metastatic disease at imaging (validated in multidisciplinary team
evaluation),
- Histology of other than adenocarcinoma,
- Any medical (including cardiovascular, respiratory, psychiatric, musculoskeletal, or
neurological) condition contra-indicating exercise practice,
- Patients with medical contraindication to surgery due to general condition or
comorbidities
- Pregnancy or breast-feeding,
- Patient under a legal protection regime (guardianship, curatorship, judicial
safeguard) or administrative decision or incapable of giving his/her consent,