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

NCT ID: NCT06275737

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2028-06-30

Brief Summary

This is a multicenter, two-cohort, open-label, single-arm feasibility study. The primary objective is to assess the feasibility of the 8-week trimodal prehabilitation program alongside perioperative triplet chemotherapy in eligible patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) .

Detailed Description

The POP-UP study aims to evaluate the feasibility and preliminary efficacy of an 8-week trimodal pre/posthabilitation program (consisting of personalized Adapted Physical Activity [APA], nutritional assessment, and psychological support) with remote monitoring of the APA sessions and nurse coordination in patients with localized (resectable or borderline resectable) PDAC who are treated with neoadjuvant or induction treatment (FOLFIRINOX: 5-fluorouracil/folinic acid, oxaliplatin, irinotecan) prior to surgery and with resectable OGC treated with perioperative chemotherapy (FLOT: 5-fluorouracil/folinic acid, oxaliplatin, docetaxel).

The prehabilitation program will be conducted during neoadjuvant chemotherapy and the 3-5 weeks prior to surgery for a total of 8 weeks before surgery. There will be a total of three prehabilitation hospital days during the prehabilitation program.

The preoperative prehabilitation will include:

• Once per month, a prehabilitation hospital-day with functional capacities assessment with validated tests made by a physiotherapist or an APA professional (according of center resources/functioning), medical and nurse assessment evaluating performance status, chemotherapy toxicity and tolerance, and nutritional assessment (according to the functioning of each center it will be made by these professionals -with university training on nutrition- or a dietician). A therapeutic training session on the adherence to the prehabilitation program will be done by the nurse (trained in therapeutic education).
• Weekly, an APA professional trainer will follow via using app (Activiti®) the APA home-based program. It will be based on the functional capacities assessment made during the prehabilitation hospital day. The exercise training program will consist of twice per week autonomy sessions, supervised and adapted by the APA professional, and once per week a guided session with the APA professional. The patient will have a total of 3 physical activity sessions per week.
• Once per week, the nurse practitioner (or case manager, according to center functioning) will evaluate the patient via a videoconference to assess the chemotherapy toxicity and tolerance and patient's weight modifications.

The posthabilitation program will start for a total of 8 weeks, one week after surgery discharge. The structure is the same as the prehabilitation program except for the follow of chemotherapy toxicity and tolerance that will be replaced by the follow of the surgical complications/consequences.

There will be a total of three posthabilitation days at hospital during the posthabilitation program.

Conditions

Pancreatic Ductal Adenocarcinoma; Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cohort 1 and Cohort 2

Cohort 1 - Patients with PDAC

Cohort 2 - Patients with OGC

Group Type: OTHER

Prehabilitation program

Intervention Type: 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)

Interventions

Prehabilitation program

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)

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy Neuzillet, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie, Saint-Cloud

Locations

Centre Hospitalier Universitaire de Lille

Lille, , France

Site Status: RECRUITING

Institut Paoli Calmettes

Marseille, , France

Site Status: RECRUITING

Institut Curie

Saint-Cloud, , France

Site Status: RECRUITING

Institut de Cancerologie de L'Ouest Rene Gauducheau

Saint-Herblain, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie-Line GARCIA LARNICOL, MD

Role: CONTACT

marie-line.garcia-larnicol@gercor.com.fr

+33 (01) 40 29 85 04

Eva Ester MOLINA BELTRAN

Role: CONTACT

evaester.molinabeltran@curie.fr

Facility Contacts

PIESSEN Guillaume, MD

Role: primary

Brice CHANEZ, MD

Role: primary

Cindy NEUZILLET, MD

Role: primary

Damien VANSTEENE, MD

Role: primary

Other Identifiers

POP-UP G-128

Identifier Type: -

Identifier Source: org_study_id