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Protocol No. NRGGI001

Principal Investigator Bassetti, Michael

Phase III

Age Group Adult

Scope National

Sponsor Type National

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

Objective The purpose of this research study is to compare any good and bad side effects of radiation therapy to the liver after completing chemotherapy to no additional treatment after chemotherapy (the usual approach). This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach of observation.

Treatment This study has two study groups. Group 1 will get radiation therapy directed at the liver cancer. Group 2 will not receive any additional treatment and will be observed (the usual approach).

Description A computer will by chance assign you to a treatment group in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other. You will have a 67% chance of being placed in group 1 and a 33% chance of being placed in group 2. You are 2 times as likely to receive the experimental treatment (group 1) in this study. Patients assigned to Group 1 will receive radiation for about 3 weeks. After you finish your treatment your doctor will continue to watch you for side effects and follow your condition every 3 months for 3 years then every 6 months for 2 years. Patients assigned to Group 2 will not receive any treatment and also will be followed every 3 months for 3 years then every 6 months for 2 years.

Key Eligibility
  • Pathologically proven diagnosis of intrahepatic cholangiocarcinoma (IHC) without distant extrahepatic metastasis prior to study entry
  • Patient must have 1 lesion with a maximum AXIAL diameter of 12cm at the time of study entry. Up to 3 satellite lesions are permitted
  • Must have received 6 months of Gemcitabine/Cisplatin chemotherapy without progression. Disease response to chemotherapy is also permitted.If toxicity precludes 6 months of chemotherapy at least 4 months of Gemcitabine/Cisplatin must have been administered
  • Patients with hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed at the time of study entry are ineligible
  • Patients with prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields are excluded
  • Patients with prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time
  • Patients with direct tumor extension into the stomach, duodenum, small bowel or large bowel are excluded
  • Patients with prior systemic chemotherapy for the study cancer other than gemcitabine/cisplatin
  • Participants who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin
  • Patients with prior surgery for the IHC are excluded (Liver resection is not allowed)
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception are excluded
  • Patients with grade 3 or higher peripheral neuropathy at the time of study entry are excluded

Applicable Disease Sites Liver

Therapies Involved Not Applicable; Radiotherapy

Status Open

Participating Institutions UW Hospital and Clinics