Clinical Trial: Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer

Brief Summary: This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.

Detailed Summary:

Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B

  • Treatment will be administered on an outpatient basis.
  • Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine .
  • Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer

Sponsor: Massachusetts General Hospital

Current Primary Outcome: Survival Rate at 18 Month [ Time Frame: 18 Month ]

Number of participants surviving after 18 months of study follow-up


Original Primary Outcome: Survival Rate at 18 Month [ Time Frame: 18 Month ]

Current Secondary Outcome:

  • Pathologic Complete Response Rate (pCR). [ Time Frame: 18 Months ]
    Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.
  • Overall Survival Rate [ Time Frame: Baseline, 5 Years ]
    Overall survival rate at five years using Kaplan-Meier survival analysis
  • Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: Baseline, 28 Days ]
    Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days
  • Surgical Morbidity Rate [ Time Frame: within 30 days of surgery ]
    Number of patients experiencing a specific surgery related morbidity
  • 30-day Post-operative Mortality Rate [ Time Frame: 30 Days ]
    Number of patients who died following surgery.
  • Correlation of Biomarkers With PFS [ Time Frame: 2 Years ]
    Analysis of the correlation between selected bio-markers and progression free survival.
  • Rate of Pathologic Downstaging [ Time Frame: 2 Years ]
    The number of participants achieving a reduction in the pathological staging of the primary cancer.
  • Local Control Rate [ Time Frame: 2 Years ]
    The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.


Original Secondary Outcome:

  • Pathologic Complete Response Rate (pCR). [ Time Frame: 18 Months ]
  • Overall Survival Rate [ Time Frame: Baseline, 5 Years ]
    Kaplan-Meier
  • Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: Baseline, 28 Days ]
  • Surgical Morbidity Rate [ Time Frame: within 30 days ]
  • 30-day Post-operative Mortality Rate [ Time Frame: 30 Days ]
  • Correlation of Biomarkers With PFS [ Time Frame: 2 Years ]
  • Rate of Pathologic Downstaging [ Time Frame: 2 Years ]
  • Local Control Rate [ Time Frame: 2 Years ]


Information By: Massachusetts General Hospital

Dates:
Date Received: September 15, 2014
Date Started: September 2014
Date Completion:
Last Updated: April 10, 2017
Last Verified: April 2017