New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04481204
Phase
PHASE2
Status
Withdrawn

Conditions

  • Borderline Resectable Pancreatic Adenocarcinoma
  • Locally Advanced Pancreatic Ductal Adenocarcinoma
  • Resectable Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Gemcitabine — DRUG
    Given IV
  • Irinotecan — DRUG
    Given IV
  • Leucovorin — DRUG
    Given IV
  • Nab-paclitaxel — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Radiation Therapy — RADIATION
    Undergo RT

Study Details

This is a phase II study using the Bayesian platform design. There are three clinical stage groups of localized pancreatic cancer: resectable, borderline resectable, and locally advanced disease. Each stage group will have a defined standard of care chemotherapy regimen for a control arm, serving as a basis of comparison. Each group may have one or more experimental arms. Experimental arms may be added to the platform over time, and the effects of the experimental treatments will be tested against the controls for each group.

Key Dates

Start date
Apr 18, 2023
Status verified
Apr 2026
Primary completion
Apr 27, 2026
Completion
Apr 27, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control arm GroupI(mFOLFIRINOX)
    Patients receive mFOLFIRINOX for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Control arm GroupII(chemotherapy, FOLFIRINOX)
    Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for up to 4 months in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Control arm GroupIII(FOLFIRINOX, radiation therapy)
    Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
  • Active Comparator: Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy)
    Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
  • Active Comparator: Control arm GroupV(FOLFIRINOX, radiation therapy)
    Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors
  • Active Comparator: Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)
    Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors

Primary Outcome Measure

Major pathological response rate [ Time Frame: 12 weeks ]

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