Trimodal prehabilitation program for patients with 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
This study is testing an 8-week program that combines exercise, nutrition help, and mental support for patients with pancreatic or esophageal cancer to see if it can improve their health before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GERCOR - Multidisciplinary Oncology Cooperative Group Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Lille and 3 other locations) |
| Trial ID | NCT06275737 on ClinicalTrials.gov |
What this trial studies
The POP-UP study is a multicenter, open-label feasibility study designed to evaluate an 8-week trimodal prehabilitation program for patients with localized pancreatic ductal adenocarcinoma or esophageal cancer. This program includes personalized adapted physical activity, nutritional assessment, and psychological support, all monitored remotely. Patients will undergo this prehabilitation during neoadjuvant chemotherapy and the weeks leading up to surgery, with assessments conducted by trained professionals to evaluate their functional capacities and overall health. The study aims to determine the feasibility and preliminary efficacy of this approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with localized pancreatic ductal adenocarcinoma or esophageal cancer who are eligible for neoadjuvant chemotherapy.
Not a fit: Patients with prior treatment for pancreatic or esophageal cancer or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance the physical and psychological readiness of patients for surgery, potentially improving surgical outcomes and recovery.
How similar studies have performed: Other studies have shown promising results with prehabilitation programs in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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). Exclusion Criteria: * 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,
Where this trial is running
Lille and 3 other locations
- Centre Hospitalier Universitaire de Lille — Lille, France (Recruiting)
- Institut Paoli Calmettes — Marseille, France (Recruiting)
- Institut Curie — Saint-Cloud, France (Recruiting)
- Institut de Cancerologie de L'Ouest Rene Gauducheau — Saint-Herblain, France (Recruiting)
Study contacts
- Principal investigator: Cindy Neuzillet, MD — Institut Curie, Saint-Cloud
- Study coordinator: Marie-Line GARCIA LARNICOL, MD
- Email: marie-line.garcia-larnicol@gercor.com.fr
- Phone: +33 (01) 40 29 85 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.