POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer

Launched by GERCOR - MULTIDISCIPLINARY ONCOLOGY COOPERATIVE GROUP · Feb 16, 2024

Keywords

ClinConnect Summary

The POP-UP clinical trial is exploring a new approach to help patients with localized pancreatic cancer or esophageal cancer prepare for surgery and chemotherapy. This study is testing an 8-week program that combines exercise, nutrition, and psychological support—called trimodal prehabilitation—alongside a type of chemotherapy that uses three medicines. The goal is to see if this program can help patients get ready for their treatment and recovery.

To participate in this trial, patients need to be 18 years or older and have a confirmed diagnosis of localized pancreatic ductal adenocarcinoma or esophageal cancer. They should not have received any previous treatment for their cancer and must meet certain health criteria, including being able to perform daily activities with minimal assistance. Throughout the study, participants can expect to follow the prehabilitation program and receive chemotherapy for about eight weeks, with regular check-ins to monitor their progress. This research is important because it may lead to better support for patients undergoing cancer treatment, improving their overall health and outcomes.

Gender

ALL

Eligibility 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,