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

NCT06275737 | Recruiting

• 1 other identifier: POP-UP G-128
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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) .

Conditions

Pancreatic Ductal Adenocarcinoma; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of patients with successful completion of an 8-week trimodal prehabilitation program

  The success of prehabilitation is defined by the achievement of the following three criteria: 1. Completion of at least 75% of the planned APA sessions: 6 of 8 sessions with an APA professional and 12 of 16 sessions in autonomy with remote APA supervision and 2. Completion of at least 75% of the nutritional evaluations: 6 of 8 planned evaluations and 3. Psychological or psychiatric visit before the surgery in function of practice center /resources if a psychological need is shown by Hospital Anxiety and Depression Scale

  8 weeks

Secondary Outcomes (16)

• Success rate (as defined above) for Adapted Physical Activity (APA), nutritional, and psychological interventions measured separately.

  8 weeks

• Health-related quality of life (HRQoL) assessment

  Up to 3 years

• Rate of patients who start and complete post-habilitation Adapted Physical Activity (APA) sessions

  8 weeks

• Nutritional status assessment

  8 weeks

• Physical/functional test assessment

  8 weeks

Study Arms (1)

Cohort 1 and Cohort 2

OTHER

Cohort 1 - Patients with PDAC Cohort 2 - Patients with OGC

Other: Prehabilitation program

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)

Cohort 1 and Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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).

You may not qualify if:

• 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,

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (4)

Centre Hospitalier Universitaire de Lille

Lille, France

RECRUITING

Institut Paoli Calmettes

Marseille, France

RECRUITING

Institut Curie

Saint-Cloud, France

RECRUITING

Institut de Cancerologie de L'Ouest Rene Gauducheau

Saint-Herblain, France

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Cindy Neuzillet, MD

  Institut Curie, Saint-Cloud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Line GARCIA LARNICOL, MD

CONTACT

+33 (01) 40 29 85 04; marie-line.garcia-larnicol@gercor.com.fr

Eva Ester MOLINA BELTRAN

CONTACT

evaester.molinabeltran@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-cohort, open-label, single-arm feasibility study

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 23, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)