POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients With Pancreatic Ductal Adenocarcinoma and Oesogastric

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.

Interventions

• Prehabilitation program · OTHER

  Cohort 1 - Prehabilitation program will be implemented during the last cycles of neoadjuvant chemotherapy (cycle 5 - cycle 6 or cycle 6 - cycle 8) and the weeks preceding surgery (planned 3-4 weeks after the last chemotherapy cycle) Cohort 2 - Prehabilitation program will be implemented during the last cycles of neoadjuvant chemotherapy (cycle 2 - cycle 4) and the weeks preceding surgery (planned 3-4 weeks after the last chemotherapy cycle)

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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,

Sites (11)

• 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
• CHU de Reims, Reims, France · Not yet recruiting
• CENTRE HOSPITALIER UNIVERSITAIRE ROUEN - CHU Charles Nicolle, Rouen, France · Not yet recruiting
• INSTITUT CURIE de SAint Cloud, Saint-Cloud, France · Recruiting
• Institut de Cancerologie de L'Ouest Rene Gauducheau, Saint-Herblain, France · Not yet recruiting
• Groupe hospitalier Rance Emeraude (CHU Saint-Malo), St-Malo, France · Not yet recruiting
• Centre Hospitalier Universitaire Tours - Hopital Trousseau, Tours, France · Not yet recruiting