RecruitingNot ApplicableNCT06275737

POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer

Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Enrollment

72 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Pancreatic Ductal Adenocarcinoma

Summary

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) .

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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).

Exclusion Criteria6

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,

Interventions

OTHERPrehabilitation program

Cohort 1 - Prehabilitation program will be implemented during the last cycles of neoadjuvant chemotherapy (cycle 5 - cycle 6 or cycle 6 - cycle 8) and the weeks preceding surgery (planned 3-4 weeks after the last chemotherapy cycle) Cohort 2 - Prehabilitation program will be implemented during the last cycles of neoadjuvant chemotherapy (cycle 2 - cycle 4) and the weeks preceding surgery (planned 3-4 weeks after the last chemotherapy cycle)