Clinical Trial: Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Two Arm, Prospective, Multicenter Randomized Phase II Trial of Neoadjuvant Modified Folfirinox Regimen, With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectabl

Brief Summary: This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.

Detailed Summary:

Surgery, especially if followed by adjuvant chemotherapy, offers the only chance of cure of pancreatic cancer. At first diagnosis, after careful assessment, only 10 to 15% of patients are considered to be candidates for surgical resection and about 7% have a potentially resectable disease. These potentially resectable tumors called "borderline resectable pancreatic cancer" (BRPC) are conceptualized as those that involve the mesenteric vasculature to a limited extent and those for which resection, while possible, would likely be compromised by positive surgical margins (R1) in the absence of neoadjuvant treatment. R0 resection is indeed considered as an independent prognostic factor for survival when the surgical procedures, histological examination and definition of microscopic invasion are standardized.

The objectives of neoadjuvant treatments of BRPC is to reduce tumor volume before surgery in order to improve the chances of radical (R0) resection and to reduce the rate of lymph node positivity and recurrences. The primary outcome in published studies is usually R0 resection rate, but these results also depend on the number of margins examined and the definition of microscopic margin involvement. Prospective studies with consistent selection criteria and standardized assessment criteria are needed.

Different neoadjuvant therapeutic strategies have been tested in pilot studies: preoperative chemoradiotherapy or neoadjuvant chemotherapy, followed or not by a preoperative (chemo)radiotherapy. Due to the lack of randomized studies, the best sequence of treatment administration has not been established.

The aim of this prospective, randomized, multicenter, trial is to evaluate the R0 resection rate with neoadjuvant Folfirinox, followed or not by radiochemotherapy for
Sponsor: Institut de Cancérologie de Lorraine

Current Primary Outcome: To assess the efficacy of two neoadjuvant therapies in patients with borderline resectable pancreatic carcinoma evaluated on histological R0 resection margin rate [ Time Frame: up to 7.5 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluate the toxicities associated with chemotherapy and chemoradiotherapy [ Time Frame: up to 7 years ]
  • Evaluate the proportion of resected patients [ Time Frame: up to 7.5 months ]
  • Evaluate the response rate to chemotherapy and chemoradiotherapy [ Time Frame: up to 7.5 months ]
  • Evaluate the histological complete response rate in resected patients. [ Time Frame: up to 7.5 months ]
  • Evaluate the perioperative mortality rate [ Time Frame: up to 8.5 months ]
  • Evaluate the perioperative morbidity rate [ Time Frame: up to 8.5 months ]
  • Evaluate the overall survival [ Time Frame: up to 7 years ]
  • Evaluate the quality of life [ Time Frame: up to 7.5 months ]
  • Evaluate the loco-regional relapse-free survival [ Time Frame: 7 years ]
  • Evaluate the metastatic Progression Free Survival [ Time Frame: 7 years ]
  • Evaluate the progression-free survival [ Time Frame: 7 years ]


Original Secondary Outcome: Same as current

Information By: Institut de Cancérologie de Lorraine

Dates:
Date Received: February 3, 2016
Date Started: June 2016
Date Completion: January 2023
Last Updated: February 27, 2017
Last Verified: February 2017