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)
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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,
Primary outcome measure(s)
The feasibility of personalized, 8-week trimodal pre-habilitation program alongside perioperative triplet chemotherapy — 8 weeks The success of pre-habilitation is defined by the achievement of the following three criteria:
1. At least 75% of the (minimum) planned APA sessions, 6 of 8 sessions with an APA professional and 12 of 16 sessions in autonomy with remote APA supervision (note: the total number of APA sessions can be adapted according to the physical activity level of the patient, with a minimum of 8 supervised sessions and 16 autonomy sessions) 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 (HADS).
Trial sites (11)
Facility
City
Region
Status
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
More GERCOR - Multidisciplinary Oncology Cooperative Group trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
