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Protocol # 20-459

Status

Recruiting

Description

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

Condition

  • Pancreatic Adenosquamous Carcinoma
  • Resectable Pancreatic Adenocarcinoma
  • Pancreatic Cancer

Interventions

  • Oxaliplatin
  • Irinotecan Hydrochloride
  • Leucovorin Calcium
  • Fluorouracil
  • Resection
  • Questionnaire Administration

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Overall survival (OS)

Secondary Outcome:

  • Disease-free survival (DFS)
  • Time to locoregional recurrence (TLR)
  • Time to distant metastases (TDM)
  • R0 resection rate
  • Rate of unresectability
  • Pathologic complete response (pCR) rate
  • Incidence of adverse events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0)
  • Fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (modified [m]FOLFIRINOX) dose intensity delivered
  • Fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified [m]FOLFIRINOX) number of cycles received
  • Quality of life as assessed by the physical functioning, nausea/vomiting, and diarrhea subscales in the Quality of Life Questionnaire-Core 30 (QLQ-C30)
  • Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on overall survival
  • Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on disease-free survival (DFS)
  • Influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the risk of grade 3+ adverse event associated with chemotherapy
  • The ability of computed tomography (CT)-based radiomics to distinguish post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor as measured by comparison to histological evaluation
  • Computed tomography (CT)-based radiomics as non-invasive predictors of overall survival

Enrollment

352

Study Start Date

July 1, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Alliance for Clinical Trials in Oncology

Source

Alliance for Clinical Trials in Oncology

Official title

A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

Clinicaltrials.gov Identifier

NCT04340141

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.