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POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients With Pancreatic Ductal Adenocarcinoma and Oesogastric

Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group • ClinicalTrials.gov ID: NCT06275737

Registry updated: 2026-09-17

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Description

This is a prospective, multicenter, two-cohort, open-label, single-arm feasibility study of a trimodal (nutritional, psychological, and personalized Adapted Physical Activity (APA)-individualized interventions) 8-week prehabilitation program in patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) receiving peri-operative triple chemotherapy and undergoing surgery.

Interventions

Prehabilitation program (Other)
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)

Eligibility criteria

Inclusion Criteria: 1. Signed and dated patient informed consent form (ICF) and willingness to comply with all study procedures and availability for the study duration, 2. Histologically or cytologically proven, localized PDAC or OGC, 3. Indication to a neoadjuvant treatment with triplet chemotherapy for ≥ 4 cycles (8 weeks) validated by the multidisciplinary board, Note: Patient treated for PDAC, dose reduction of oxaliplatin or irinotecan is authorized. 4. Age \> 18 years; If aged ≥ 75 years: G8 score must be ≥ 14 and if \< 14 validation of oncogeriatric specialist, 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 at the inclusion visit, 6. No prior treatment for PDAC or OGC before starting chemotherapy (FLOT or FOLFIRINOX), 7. 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, 8. Adequate hematologic and end-organ function allowing the triple combination chemotherapy protocol, 9. Registration in a national health care system (PUMa - Protection Universelle Maladie included). Exclusion Criteria: 1. Evidence of metastatic disease at imaging (validated in multidisciplinary team evaluation), 2. Histology of other than adenocarcinoma, 3. Any medical (including cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice, 4. Patients with medical contraindication to surgery due to general condition or comorbidities 5. Pregnancy or breast-feeding, 6. Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent,

Conditions

Pancreatic Ductal Adenocarcinoma Esophageal Cancer

Locations

Centre Hospitalier Universitaire Dijon Bourgogne — Dijon, France
Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble — Grenoble, France
Centre Hospitalier Universitaire de Lille — Lille, France
Hospital La Timone — Marseille, France
Institut Paoli-Calmettes — Marseille, France
CHU de Reims — Reims, France
CENTRE HOSPITALIER UNIVERSITAIRE ROUEN - CHU Charles Nicolle — Rouen, France
INSTITUT CURIE de SAint Cloud — Saint-Cloud, France
Institut de Cancerologie de L'Ouest Rene Gauducheau — Saint-Herblain, France
Groupe hospitalier Rance Emeraude (CHU Saint-Malo) — St-Malo, France
Centre Hospitalier Universitaire Tours - Hopital Trousseau — Tours, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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