A Phase II Study Comparing Chemotherapy Alone and with Radiation Therapy before Surgery in Patients with Borderline Operable Pancreatic Cancer

Full Title

NCTN: A021501: Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

Purpose

Patients with borderline operable pancreatic cancer have tumors that could possibly be surgically removed if they shrank following treatment before surgery, like chemotherapy and radiation therapy. In this study, researchers are comparing presurgical chemotherapy alone with presurgical chemotherapy plus radiation therapy in patients with borderline operable pancreatic cancer. They want to see if one approach is more effective than the other for shrinking tumors enough so they can be surgically removed, and for helping patients live longer.

Patients in this study will be randomly assigned to receive eight cycles of a combination of intravenous chemotherapy drugs before surgery, or seven cycles of the same chemotherapy as well as one week of radiation therapy before surgery. All patients will also have four cycles of a different chemotherapy combination after surgery.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have borderline operable pancreatic cancer that has not yet been treated with chemotherapy or radiation therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eileen O’Reilly at 646-888-4182.

Protocol

17-210

Phase

II

Investigator

Co-Investigators