Pancreatic Cancer RTOG 0848

April 11, 2017

Sponsor: National Cancer Institute (NCI)

Number: RTOG 0848

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II-R/III (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) trial. This trial studies Gemcitabine Hydrochloride with or without Erlotinib Hydrochloride, followed by the same chemotherapy regimen with or without radiation therapy, and Capecitabine or Fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Chemotherapy drugs used, such as Gemcitabine Hydrochloride, Capecitabine, and Fluorouracil, work in different ways to stop the growth of tumor cells. The drugs work either by killing the cells, stopping them from dividing, or by stopping them from spreading. Erlotinib Hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without Erlotinib Hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without Erlotinib Hydrochloride and/or radiation therapy in treating pancreatic cancer.

Who’s eligible:

• Histologic proof (tissue microscopically examined) of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (or whipple, a surgery removing the head of the pancreas) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible.
• For patients who have not started their chemotherapy prior to registration. The interval between definitive tumor-related surgery and first step registration must be between 21-70 days.
• For patients entering on the study who have already received up to three months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days.
• This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, MidState Medical Center.