POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients … (NCT06275737) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients With Pancreatic Ductal Adenocarcinoma and Oesogastric
France9 participantsStarted 2024-06-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 proven, localized PDAC or OGC,
✓. 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.
✓. 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 the inclusion visit,
✓. No prior treatment for PDAC or OGC before starting chemotherapy (FLOT or FOLFIRINOX),
✓. 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,
✓. Adequate hematologic and end-organ function allowing the triple combination chemotherapy protocol,
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,
What they're measuring
1
The rate of eligible patients with successful completion of the 8-week trimodal prehabilitation program
Timeframe: 8 weeks
Trial details
NCT IDNCT06275737
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
✕. 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,