Pancreatic Ductal AdenocarcinomaPOP-UPNCT06275737
POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients With Pancreatic Ductal Adenocarcinoma and Oesogastric
A study testing Prehabilitation program in people with Pancreatic Ductal Adenocarcinoma and Esophageal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 11 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
- What is being tested?
- Prehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 11 sitesFrance
- Study dates
- 24 Jun 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 proven, localized PDAC or OGC,
- 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.
- 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 the inclusion visit,
- No prior treatment for PDAC or OGC before starting chemotherapy (FLOT or FOLFIRINOX),
Show all 9Show fewer
- 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,
- Adequate hematologic and end-organ function allowing the triple combination chemotherapy protocol,
- Registration in a national health care system (PUMa - Protection Universelle Maladie included).
Who cannot join
- 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,
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eva Ester MOLINA BELTRAN contact
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon
Olivier FACY, MD
- Not yet recruiting
Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
Grenoble
Camille HERVE, MD
- Not yet recruiting
Centre Hospitalier Universitaire de Lille
Lille
PIESSEN Guillaume, MD
- Not yet recruiting
Hospital La Timone
Marseille
Laetitia DAHAN, MD
- Not yet recruiting
Institut Paoli-Calmettes
Marseille
Brice CHANEZ, MD
- Not yet recruiting
CHU de Reims
Reims
Olivier BOUCHE, MD
- Not yet recruiting
CENTRE HOSPITALIER UNIVERSITAIRE ROUEN - CHU Charles Nicolle
Rouen
Lilian SCHWARZ, MD
- Recruiting
INSTITUT CURIE de SAint Cloud
Saint-Cloud
Cindy NEUZILLET, MD
- Not yet recruiting
Institut de Cancerologie de L'Ouest Rene Gauducheau
Saint-Herblain
Damien VANSTEENE, MD
- Not yet recruiting
Groupe hospitalier Rance Emeraude (CHU Saint-Malo)
St-Malo
Anais BODERE, MD
- Not yet recruiting
Centre Hospitalier Universitaire Tours - Hopital Trousseau
Tours
Thierry LECOMTE, MD
About this study
Official title: Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study
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.
Read the detailed description
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.
- Being tested
- Prehabilitation program
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation programOther
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 group | Role | What they receive |
|---|---|---|
| Cohort 1 and Cohort 2 | Other | Cohort 1 - Patients with PDAC
Cohort 2 - Patients with OGC Receives: Other: Prehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of personalized, 8-week trimodal pre-habilitation program alongside perioperative triplet chemotherapy
The success of pre-habilitation is defined by the achievement of the following three criteria:
- 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
- Completion of at least 75% of the nutritional evaluations: 6 of 8 planned evaluations and
- 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).
Measured: 8 weeks
Secondary outcomes (29)
Success rate of APA, nutritional, and psychological interventions
Evaluates completion and adherence of each intervention separately according to predefined success criteria. Unit of Measure: Proportion of patients (%) achieving predefined success criteria
Measured: 8 weeks
Overall survival (OS) assessment
OS defined as time (months) between the date of inclusion and 12 months after surgery
Measured: up to 12 months after surgery
Disease-free survival (DFS) assessment
DFS defined as the time (months) between the date inclusion and the date corresponding at 12 months after surgery
Measured: up to 12 months after surgery
Health-related quality of life assessment by EORTC QLQ-C30
HRQoL will be assessed by using the EORTC QLQ-C30 questionnaire at screening, once per month and at the end of intervention visit. The EORTC QLQ-C30 is a cancer specific questionnaire assessing 15 HRQOL scales through 30-items; for each dimension, one score is generated according to the recommendations of the EORTC on a 0-100 scale in order that a high score represents a high functional level, a high Global QoL level, and a high symptomatic level.
Measured: Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
Health-related quality of life assessment by EORTC QLQ-PAN26
The EORTC QLQ-PAN26 is a module specific to pancreatic cancer, to be used in conjunction to the EORTC QLQ-C30. It contains 26 items. As for the EORTC QLQ-C30, one score is generated for each score according to the recommendations of the EORTC on a 0-100 scale in order that a high score represents a high functional level and a high symptomatic level.
Measured: Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
Health-related quality of life assessment by EORTC QLQ-OG25
The EORTC QLQ-OG25 is a module specific to esophago-gastric cancer to use in conjunction to the EORTC QLQ-C30. It contains 25 items. One score is generated for each score according to the recommendations of the EORTC on a 0-100 scale in order that a high score represents a high functional level and a high symptomatic level
Measured: Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
Chemotherapy tolerance assessment
The chemotherapy tolerance with the CTCAE V5.0 (Grade ≥ 3) will be evaluated. Unit of Measure: Number and proportion of patients with Grade ≥3 toxicities (CTCAE v5.0) Toxicities requiring hospitalization, treatment delays, and dose reductions related to toxicity will also be assessed
Measured: 8 weeks
Postoperative complications assessment
Major postoperative complications will be measured. Unit of Measure: Number/proportion of patients with Clavien-Dindo Grade ≥3 complications - evaluates serious surgical complications requiring intervention under anesthesia, ICU care, or resulting in death.
Measured: Surgery and postoperative period (up to 90 days post-surgery)
Nurse intervention assessment
The nurse intervention will be evaluated by: Unit of Measure: Number of alerts managed by nurses and oncologists, Weekly remote follow-up completion rate (%), Scheduled vs. completed prehabilitation/posthabilitation sessions (%), and Hospital days
Measured: 8 weeks
Adherence to APA program assessment
Tracks patient participation in post-habilitation APA sessions and documents reasons for drop-out. Unit of Measure: Number and proportion of patients completing sessions (%). Adherence will also be evaluated using patient-reported outcomes collected through the Activiti® application and APA professional assessments, including the number of APA sessions performed and APA dose intensity.
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9
Pancreatic function assessment
Fecal elastase and pancreatic enzyme use will be assessed. Unit of Measure: Levels of fecal elastase (µg/g) and pancreatic enzyme consumption (units/day).
Measured: week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
G-CSF use and neutropenia assessment
Hematologic support and neutropenia will be evaluated. Unit of Measure: G-CSF prescription (yes/no), rate of grade ≥2 neutropenia (%)
Measured: 8 weeks
Surgical rate assessment
Surgical rate will be assessed. Unit of Measure: Number/proportion of patients with surgery
Measured: Surgery and postoperative period
Perioperative chemotherapy rate assessment
Assessing completion of scheduled perioperative chemotherapy cycles in eligible patients. Unit of Measure: Number/proportion of patients with planned vs received number of perioperative chemotherapy cycles.
Measured: 8 weeks
Chemotherapy dose received
Relative dose intensity will be measured. Unit of Measure: Percentage of planned dose received (%)
Measured: 8 weeks
Nutritional Status Assessment - Body composition
Evaluating changes in skeletal muscle and fat mass to assess nutritional status during the prehabilitation program. Outcome Measure: Skeletal muscle and adipose tissue areas. Unit of Measure: cm² (cross-sectional area at L3 via TAP-CT or bioimpedance)
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - weight and BMI
Evaluating changes in body weight and BMI to monitor nutritional status. Unit of Measure: kg (weight), kg/m² (BMI).
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - Food intake
Measuring dietary intake and eating behavior to assess nutritional status. Unit of Measure: Simple Evaluation of Food Intake (SEFI) visual analog scale. The score is reported using the SEFI visual analog scale, which ranges from 0 to 10, where higher scores indicate better food intake.
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - Serum Albumin evaluation
Evaluating nutritional status through Serum Albumin evaluation. Unit of Measure: g/L. Meaning: Higher albumin levels indicate better nutritional status and overall protein reserves.
Interpretation:
Good: Higher values (within normal laboratory range) Bad: Lower values (may indicate malnutrition or poor protein intake)
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - C-Reactive Protein (CRP) evaluation
Evaluating inflammatory status through CRP levels. Unit of Measure: mg/L. CRP is a marker of inflammation. Lower CRP indicates lower inflammatory activity.
Interpretation:
Good: Lower values (normal or near-normal, minimal inflammation) Bad: Higher values (indicating active inflammation or possible infection)
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - Complete Blood Count (CBC) Parameters evaluation
Description: Evaluating general health and nutritional status through CBC parameters (e.g., hemoglobin, hematocrit, leukocytes). Unit of Measure: Standard laboratory units (e.g., g/dL for hemoglobin, cells/µL for leukocytes). Meaning: CBC evaluates general health and nutritional status (e.g., hemoglobin for anemia, leukocytes for immune status).
Interpretation:
Good: Values within normal reference ranges Bad: Values outside normal ranges (e.g., low hemoglobin = anemia, abnormal leukocytes = possible infection or immune dysfunction)
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Functional Status Assessment - Behavioral changes in physical activity (International Physical Activity Questionnaire [IPAQ-S])
Assessing daily physical activity using IPAQ-S. It is a 7-item questionnaire in which duration (hours and minutes per day), frequency (times per week), and intensity (walking, moderate and vigorous) of the previous 7 days will be collected. Sedentary time (self-reported time spent sitting) in the same time period will be recorded (hours/min/day).Unit of Measure: MET-min/week and Minutes/day.
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months)
Functional Status Assessment - 6-minute walk test
Assessing functional exercise capacity. Outcome Measure: Walking distance (meters).
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Handgrip strength
Assessing upper body muscle strength. Unit of Measure: Kilograms (kg)
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Sit-to-stand test (STS)
Measuring lower limb strength and functional capacity. Unit of Measure: Repetitions per minute
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Borg scale
Measuring subjective exertion during functional tests. Unit of Measure: Score. Score on the Borg scale ranges from 6 (no exertion) to 20 (maximal exertion). Lower scores indicate lighter effort (better functional tolerance), higher scores indicate greater perceived exertion (more strain).
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Balance
Measuring balance and stability. Unit of Measure: Seconds
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Time Up and Go (≥70 years)
Measuring mobility and fall risk in older patients. Unit of Measure: Seconds
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9
Hospital Anxiety and Depression Scale (HADS) assessment
The HADS is a 14-item questionnaire assessing anxiety through 7 items and depression with 7-items. One score is generated per dimension on a 0-21 scale with the sum of the corresponding items. A score between 0 and 7 represents the absence of anxiety/depression. More of 9 in HADS-anxiety (A) is considered as a presence of an anxiety disorder which needs the intervention of a psychologist (anxiety) and more of 7 in HADS-depression (D) is considered as a presence of depression disorder which needs the intervention of a psychiatrist (depression).
Measured: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start24 Jun 2024
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two-cohort, open-label, single-arm feasibility study
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy Neuzillet, MD, Principal investigator, Institut Curie, Saint-Cloud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275737
- Sponsor's protocol ID
- POP-UP G-128
- Acronym
- POP-UP
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study
- ClinicalTrials.gov ID
- NCT06275737
- Acronym / sponsor ID
- POP-UP / POP-UP G-128
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two-cohort, open-label, single-arm feasibility study
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 and Cohort 2 | Other | Other: Prehabilitation programCohort 1 - Patients with PDAC Cohort 2 - Patients with OGC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 proven, localized PDAC or OGC,
- 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.
- 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 the inclusion visit,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation programCohort 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) | Other | Cohort 1 and Cohort 2 |
Primary outcome
The feasibility of personalized, 8-week trimodal pre-habilitation program alongside perioperative triplet chemotherapy
Time frame: 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).
29 secondary outcomes
Success rate of APA, nutritional, and psychological interventions
Time frame: 8 weeks
Overall survival (OS) assessment
Time frame: up to 12 months after surgery
Disease-free survival (DFS) assessment
Time frame: up to 12 months after surgery
Health-related quality of life assessment by EORTC QLQ-C30
Time frame: Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
Health-related quality of life assessment by EORTC QLQ-PAN26
Time frame: Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
Health-related quality of life assessment by EORTC QLQ-OG25
Time frame: Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
Chemotherapy tolerance assessment
Time frame: 8 weeks
Postoperative complications assessment
Time frame: Surgery and postoperative period (up to 90 days post-surgery)
Nurse intervention assessment
Time frame: 8 weeks
Adherence to APA program assessment
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Pancreatic function assessment
Time frame: week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
G-CSF use and neutropenia assessment
Time frame: 8 weeks
Surgical rate assessment
Time frame: Surgery and postoperative period
Perioperative chemotherapy rate assessment
Time frame: 8 weeks
Chemotherapy dose received
Time frame: 8 weeks
Nutritional Status Assessment - Body composition
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - weight and BMI
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - Food intake
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - Serum Albumin evaluation
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - C-Reactive Protein (CRP) evaluation
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - Complete Blood Count (CBC) Parameters evaluation
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Functional Status Assessment - Behavioral changes in physical activity (International Physical Activity Questionnaire [IPAQ-S])
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months)
Functional Status Assessment - 6-minute walk test
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Handgrip strength
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Sit-to-stand test (STS)
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Borg scale
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Balance
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Time Up and Go (≥70 years)
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Hospital Anxiety and Depression Scale (HADS) assessment
Time frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Solid Tumors
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
RecruitingObservational study
Pancreatic Cancer Early Detection Consortium
Pancreas Cancer, Pancreas Cyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Ester MOLINA BELTRAN contact
Cindy Neuzillet, MD principal investigator
Institut Curie, Saint-Cloud
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation program in people with Pancreatic Ductal Adenocarcinoma and Esophageal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Line GARCIA LARNICOL, MD (+33 (01) 40 29 85 04, marie-line.garcia-larnicol@gercor.com.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of personalized, 8-week trimodal pre-habilitation program alongside perioperative triplet chemotherapy (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.