Trimodal prehabilitation program for patients with upper GI and pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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,

Where it's running

• INSTITUT CURIE de SAint Cloud
  Saint-Cloud, France Recruiting
• Centre Hospitalier Universitaire Dijon Bourgogne
  Dijon, France Not yet recruiting
• Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
  Grenoble, France Not yet recruiting
• Centre Hospitalier Universitaire de Lille
  Lille, France Not yet recruiting
• Hospital La Timone
  Marseille, France Not yet recruiting
• Institut Paoli-Calmettes
  Marseille, France Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.