About this trial
This is an open master platform trial, which includes multi neo-adjuvant treatment trials, multi-center, national. This platform trial evaluates the major pathological response rate (mPR) after surgery.
Intervention: The procedure consists of administering a neoadjuvant treatment and then performing pancreatic surgery. The POWER platform trial aims to study several neoadjuvant treatments prior to surgery. They will be described in each sub-study, in appendix. The surgery will be performed on one day and the end of the treatment is the safety visit post-surgery (90 days after surgery).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult, age ≥ 18 years old at the time of signing the informed consent form.
Documented informed consent.
Histologically or cytologically confirmed pancreatic adenocarcinoma.
Tumor deemed resectable based on local assessment.
Disqualifiers
Ongoing participation in clinical sub-study involving the use of an investigational product prior to registration in the sub-study.
During participation in this study, patients will not receive any other clinical investigational drugs or any other anti-tumor drugs as describes on sub-study.
Previous neoadjuvant or induction treatment for pancreatic cancer, including cytotoxic chemotherapy, immunotherapy, experimental therapy, or radiotherapy.
Uncontrolled tumor-related pain.
Trial design
Parallel
Treatments tested in this trial
GnP
DrugPOWER B - Neo adjuvant treatment (GnP) for 28 days
FOLFIRINOX
DrugPOWER A - Neo adjuvant treatment (Folfirinox) for 28 days
Treatment groups
Trial outcomes
Primary outcomes
Major pathological response rate (mPR) on surgical resection specimen
The efficacy of various experimental drugs, based on pathological response, when administered in a preoperative setting will be analyzed. The major pathological response rate (mPR) will be evaluated on the surgical resection specimen
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: