Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT06275737 En recrutement IDF

Titre

Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study

Type

Interventional

Pathologie

Tumeurs de l'oesophage

Phase

N/A

Promoteur

GERCOR - Multidisciplinary Oncology Cooperative Group (Voir sur ClinicalTrials)

Date de début

juin 2024

Date de fin

juin 2028

Dernière mise à jour

20 septembre 2026

Résumé

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.

Détail

Voir le détail The POP-UP study aims to evaluate the feasibility of an 8-week trimodal pre/posthabilitation program (consisting of APA, nutritional assessment, and psychological support) with remote monitoring of the APA sessions and nurse coordination alongside perioperative triplet chemotherapy in patients with localized PDAC (resectable or borderline resectable tumor) or OGC (≥ cT2 or N+). 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC RENE HUGUENIN INSTITUT CURIE		En recrutement IDF	10/04/2025 13:11:55	Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Hospitalier Universitaire Dijon Bourgogne - Dijon - France	Olivier FACY, MD			Contact (sur clinicalTrials)
CENTRE HOSPITALIER UNIVERSITAIRE ROUEN - CHU Charles Nicolle - Rouen - France	Lilian SCHWARZ, MD			Contact (sur clinicalTrials)
Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble - Grenoble - France	Camille HERVE, MD			Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Hospitalier Universitaire de Lille - Lille - France	PIESSEN Guillaume, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier Universitaire Tours - Hopital Trousseau - Tours - France	Thierry LECOMTE, MD			Contact (sur clinicalTrials)
CHU de Reims - Reims - France	Olivier BOUCHE, MD			Contact (sur clinicalTrials)
Groupe hospitalier Rance Emeraude (CHU Saint-Malo) - St-Malo - France	Anais BODERE, MD			Contact (sur clinicalTrials)
Hospital La Timone - Marseille - France	Laetitia DAHAN, MD			Contact (sur clinicalTrials)
INSTITUT CURIE de SAint Cloud - Saint-Cloud - France	Cindy NEUZILLET, MD			Contact (sur clinicalTrials)
Institut de Cancerologie de L'Ouest Rene Gauducheau - Saint-Herblain - France	Damien VANSTEENE, MD	En recrutement		Contact (sur clinicalTrials)
Institut Paoli-Calmettes - Marseille - France	Brice CHANEZ, MD			Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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:

Critère de non inclusion

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,

NCT06275737 - Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study

Informations générales
Etablissements
Critères
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