FOLFIRINOX + RT for Pancreatic Cancer

Description

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of a therapy to learn whether the therapy works in treating a specific cancer. "Investigational" means that the therapy is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if therapy is effective for treating different types of cancer. Proton beam radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery system. Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as it delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy, which tends to include more normal tissue along with tumor target tissue. Researchers in the laboratory have discovered that there are pathways inside the cells that can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and capecitabine are targeted towards blocking the pathways that allow cancer cells to divide, and may result in the tumor shrinking in size. In this research study, the investigators are looking to determine if proton beam radiation in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of your cancer.

Study Start Date

May 2012

Estimated Completion Date

May 2016

Interventions

  • Drug: Capecitabine
  • Radiation: Short Course Radiation
  • Procedure: Surgery
  • Drug: FOLFIRINOX
  • Radiation: Proton Radiation

Specialties

  • Internal Medicine: Gastroenterology,Hematology/Oncology
  • Nursing: Gastroenterology
  • Gastroenterology: Biliary System/Pancreas
  • Family Medicine: Gastroenterology
  • Oncology: Hepatobiliary/Pancreas
  • Physician Assistant: Gastroenterology

MeSH Terms

  • Pancreatic Neoplasms

Study ID

Massachusetts General Hospital -- 11-328

Status

Unknown

Trial ID

NCT01591733

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

50

Sponsor

Massachusetts General Hospital

Inclusion Criteria

  • Cytologic or histologic proof pancreatic ductal carcinoma
  • Borderline resectable
  • Body and tail lesions
  • Life expectancy of at least 3 months

Exclusion Criteria

  • Evidence of metastatic disease
  • Pregnant or breastfeeding
  • Other serious uncontrolled medical conditions
  • Prior chemotherapy, targeted/biologic therapy or radiation for treatment of the pancreatic tumor
  • Prior systemic fluoropyrimidine therapy
  • History of uncontrolled seizures, central nervous system disorders or psychiatric disability

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None

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