FOLFIRINOX + RT for Pancreatic Cancer

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Folfirinox; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Cytologic or histologic proof pancreatic ductal carcinoma

• Borderline resectable

• Life expectancy of at least 3 months

• ECOG Performance Status ≤ 1

• Adequate organ and bone marrow function

• No treatment of other invasive cancers within the last 5 years with greater than 5% risk of recurrence at the time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/squamous cell carcinoma of the skin are allowed

• > 4 weeks since major surgery, excluding laparoscopy

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

• Individuals on cimetidine