Clinical Trial 18941

Cancer Type: Gastrointestinal Tumor
Interventions:FOLFIRINOX; FOLFOX

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Mokenge Malafa

Overview

Study Title

Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

Summary

The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.

Objective

2.1 Primary Objective: To evaluate and estimate 18 months overall survival (OS) rate of patients with borderline resectable PDAC receiving neoadjuvant therapy consisting of one of the following regimens prior to intended surgical resection and adjuvant therapy with 4 cycles of FOLFOX: 1) Arm 1: 8 cycles of systemic FOLFIRINOX, and/or; 2) Arm 2: 7 cycles of systemic FOLFIRINOX followed by hypofractionated radiation therapy. 2.2 Secondary Objectives: 2.2.1 To evaluate and estimate the R0 resection rates in patients receiving each of the two multimodality treatment regimens. 2.2.2 To evaluate and estimate the event-free survival in patients receiving each of the two multimodality treatment regimens. 2.2.3 To evaluate and estimate the pathologic compete response (pCR) rates in patients receiving each of the two multimodality treatment regimens. 2.2.4 To assess the adverse events (AE) profile and safety of each treatment arm. 2.3 Other Objective: Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline QOL and fatigue.

Inclusion Criteria

  • Pre-Registration: Meets detailed Documentation of Disease criteria as outlined in protocol document.
  • Pathology: Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process. Diagnosis should be verified by local pathologist.
  • Disease Status: Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Participants on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Participants must discontinue the drug 14 days prior to the start of study treatment.
  • Not pregnant and not nursing. For women of childbearing potential only, a negative pregnancy test done less than or equal to 7 days prior to registration is required.
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Required Initial Laboratory Values: Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3; Platelet Count ≥ 100,000/mm^3; Creatinine ≤ 1.5 x upper limit of normal (ULN) or Calc. Creatinine Clearance > 45 mL/min; Total Bilirubin ≤ 2.0 mg/dL; AST / ALT ≤ 2.5 x ULN.

  • Exclusion Criteria

  • Grade ≥ 2 neuropathy
  • Known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism
  • Uncontrolled gastric ulcer disease (Grade 3 gastric ulcer disease) within 28 days of registration
  • Prior chemotherapy or radiation for pancreatic cancer
  • Definitive resection of pancreatic cancer
  • Pregnant or nursing