Pancreatic Adenocarcinoma Resectable, Non Metastatic, ECOG Performance Status Score of 0 or 1
Conditions
Brief summary
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).
Interventions
DRUGGnP
POWER B - Neo adjuvant treatment (GnP) for 28 days
DRUGFOLFIRINOX
POWER A - Neo adjuvant treatment (Folfirinox) for 28 days
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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. . The POWER platform trial aims to study several neoadjuvant treatments prior to surgery. They will be described in each sub-study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * No evidence of distant metastases on CT scan or PET scan, as well as liver MRI prior to registration. * ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1. * Adequate hematologic and organ function, defined by the following laboratory results obtained within 7 days prior to initiation of study treatment: 1. Neutrophils ≥ 1.5 × 10⁹/L (≥ 1500/µL) without granulocyte colony-stimulating factor support. 2. Platelet count ≥ 100 × 10⁹/L (≥ 100,000/µL) without transfusion. 3. Hemoglobin ≥ 90 g/L (≥ 9 g/dL). Patients may be transfused to meet this criterion. 4. AST, ALT, and ALP ≤ 3 × upper limit of normal (ULN). 5. Total bilirubin ≤ 1.5 × ULN.Creatinine clearance ≥ 50 mL/min (calculated using the MDRD formula). 6. Albumin ≥ 30 g/L (≥ 2.5 g/dL). 7. For patients not receiving anticoagulant therapy: INR and aPTT ≤ 1.5 × ULN. * Women of childbearing potential (WOCBP) must have a negative urine or serum β-HCG pregnancy test within 7 days prior to the registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required at 72-24 hours before starting the neo-adjuvant treatment. Sexually active female patients must agree to use two methods of effective contraception (cf. paragraph 7.10, one of them being a barrier method, or to abstain from sexual activity during the clinical investigation and for at least 6 months after last dose neoadjuvant treatment. * Sexually active males patients must agree to use condom during the clinical investigation and for at least 6 months after the neo-adjuvant treatment. Also, it is recommended the childbearing potential female partner uses a highly effective method of contraception for the same duration (see paragraph 6.12 " Pregnancy and contraception "). * Patients shall be eligible to undergo neo adjuvant treatment, surgery and tumor biopsies. * Patients must be affiliated to a social security system or beneficiary of the same. * Additional specific sub-study inclusion criteria: Patient should also meet the potential specific eligibility criteria of the sub-study for which they are screened.
Exclusion criteria
* 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. * Pregnancy or breastfeeding Pregnant or breastfeeding women or intending to become pregnant during the study. * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent. * No prior treatment including surgery, radiation therapy or systemic therapy for pancreatic adenocarcinoma. * Patients with a history of another primary malignancy diagnosed or requiring treatment within the 2 years prior to the first administration of the study drug. The following prior malignancies are not considered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response rate (mPR) on surgical resection specimen | After pancreatic surgical resection, after 28 days of treatment | 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 |
Countries
France
Contacts
CONTACTAntoine HOLLEBECQUE
CONTACTClementine MAHAUT
Outcome results
None listed