FOLFIRINOX + RT for Pancreatic Cancer

Status unconfirmed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT01591733

Run by

Massachusetts General Hospital

People needed

48

Starts

2012-05-01

Expected to finish

2022-01-01

Last updated by the study team

2021-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.