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Trial Title:
POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer
NCT ID:
NCT06275737
Condition:
Pancreatic Ductal Adenocarcinoma
Esophageal Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Two-cohort, open-label, single-arm feasibility study
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Prehabilitation program
Description:
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)
Arm group label:
Cohort 1 and Cohort 2
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.
Criteria for 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,
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire de Lille
Address:
City:
Lille
Country:
France
Status:
Recruiting
Contact:
Last name:
PIESSEN Guillaume, MD
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Brice CHANEZ, MD
Facility:
Name:
Institut Curie
Address:
City:
Saint-Cloud
Country:
France
Status:
Recruiting
Contact:
Last name:
Cindy NEUZILLET, MD
Facility:
Name:
Institut de Cancerologie de L'Ouest Rene Gauducheau
Address:
City:
Saint-Herblain
Country:
France
Status:
Recruiting
Contact:
Last name:
Damien VANSTEENE, MD
Start date:
August 2024
Completion date:
March 2027
Lead sponsor:
Agency:
GERCOR - Multidisciplinary Oncology Cooperative Group
Agency class:
Other
Source:
GERCOR - Multidisciplinary Oncology Cooperative Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06275737
