NCT06275737 POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients With Pancreatic Ductal Adenocarcinoma and Oesogastric
| NCT ID | NCT06275737 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GERCOR - Multidisciplinary Oncology Cooperative Group |
| Condition | Pancreatic Ductal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2024-06-24 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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,
Contact & Investigator
Cindy Neuzillet, MD
PRINCIPAL INVESTIGATOR
Institut Curie, Saint-Cloud
Frequently Asked Questions
Who can join the NCT06275737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Ductal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06275737 currently recruiting?
Yes, NCT06275737 is actively recruiting participants. Contact the research team at marie-line.garcia-larnicol@gercor.com.fr for enrollment information.
Where is the NCT06275737 trial being conducted?
This trial is being conducted at Dijon, France, Grenoble, France, Lille, France, Marseille, France and 7 additional locations.
Who is sponsoring the NCT06275737 clinical trial?
NCT06275737 is sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group. The principal investigator is Cindy Neuzillet, MD at Institut Curie, Saint-Cloud. The trial plans to enroll 72 participants.