Randomized Phase III Study of Focal Radiation Therapy for Unresectable, Localized Intrahepatic Cholangiocarcinoma

Study Name: NRG-GI001: Randomized Phase III Study of Focal Radiation Therapy for Unresectable, Localized Intrahepatic Cholangiocarcinoma

Institution Name: NRG Oncology, Massachusetts

Principal Investigator: Ted Hong, (617) 724-1159, TSHONG1@mgh.harvard.edu

Additional Principal Investigators:

  • Theodore Hong, MD Massachusetts General Hospital 100 Blossom Street, Boston, MA 00214, 617-724-1159/Fax: 617-726-3603 TSHONG1@mgh.harvard.edu
  • Laura A. Dawson, MD, Princess Margaret Cancer Centre University of Toronto, 610 University Avenue, Toronto, ON, Canada MSG 2M9, 416-946-2125/Fax: 416-946-6566, Laura.dawson@rmp.uhn.on.ca

Study Coordinator: Ted Hong

Study Coordinator Phone: (617) 724-1159

Study Coordinator Email: TSHONG1@mgh.harvard.edu

Overview: To evaluate the addition of liver-directed radiation therapy to chemotherapy with respect to overall survival (OS) for patients with unresectable, localized intrahepatic cholangiocarcinoma

Enrollment: 182

Study Start Date: 11/25/14

Estimated Completion Date: 6/26/19

Purpose of the Study – in Layman’s Terms: To improve the suvivial of patients with intrahepatic cholangiocarcinoma.

Inclusion Criteria – Patients Must: unresectable cholangiocarcinoma

Exclusion Criteria – Patients Must NOT: prior radiation or chemotherapy

Required Tests Prior to Beginning Study Treatment: CT or MRI, blood work

Potential Side-Effects: fatigue