Clinical trial · Interventional
POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients With Pancreatic Ductal Adenocarcinoma and Oesogastric
Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study
NCT06275737CI-TRIAL-00107352POP-UPrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cohort 1 and Cohort 2
- description
- Cohort 1 - Patients with PDAC Cohort 2 - Patients with OGC
- interventionNames
- Other: Prehabilitation program
Primary outcomes (1)
- measure
- The feasibility of personalized, 8-week trimodal pre-habilitation program alongside perioperative triplet chemotherapy
- timeFrame
- 8 weeks
- description
- The success of pre-habilitation is defined by the achievement of the following three criteria: 1. At least 75% of the (minimum) planned APA sessions, 6 of 8 sessions with an APA professional and 12 of 16 sessions in autonomy with remote APA supervision (note: the total number of APA sessions can be adapted according to the physical activity level of the patient, with a minimum of 8 supervised sessions and 16 autonomy sessions) and 2. Completion of at least 75% of the nutritional evaluations: 6 of 8 planned evaluations and 3. Psychological or psychiatric visit before the surgery in function of practice center /resources if a psychological need is shown by Hospital Anxiety and Depression Scale (HADS).
Secondary outcomes (29)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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,
References
Publications (0)
Data not yet available
No reference posted for this study.