Clinical trial for Pancreatic Ductal Adenocarcinoma
Official title POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients With Pancreatic Ductal Adenocarcinoma and Oesogastric
ClinicalTrials.gov ID: NCT06275737
What this study is testing
- What it's testing
- This is a two-cohort, 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 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...
- 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,
You likely can't join 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...
See the full eligibility 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 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...
- 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),
- 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).
- 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,
The study team makes the final eligibility decision.
Where it is enrolling
- Saint-Cloud, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Saint-Cloud, France. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.