RTOG 84-05 (LIVER)
- Title: Phase I/II Dose-Escalating Trial of Accelerated Fractionation in the Palliative Irradiation of Hepatic Metastases from Primary Cancer of the GI Tract
- I. Assess the feasibility and efficacy of a twice-daily schedule of radiation treatments in the palliation of patients with liver metastases from cancer of the stomach, pancreas, gallbladder, biliary tree, colon, or rectum.
- II. Determine whether greater doses of hepatic irradiation in a selected population of prognostically favorable patients can result in a decreasing frequency of progressive liver metastases as a direct cause of death.
- III. Help define the tolerance of the liver to fractionated irradiation delivered in dose fractions that may ultimately be clinically useful in the elective or adjuvant irradiation of the liver in high-risk patients with primary cancers draining via the portal circulation.
- Protocol: Whole liver dose escalation 27 Gy -> 36 Gy given in 1.5 Gy/fx BID
- Eligibility: Measurable hepatic metastases (as documented by CT scan) from histologically verified primary cancers arising in the stomach, pancreas, gallbladder, biliary tree, colon, or rectum. All cell types are permissible except leukemia, plasmacytoma, and lymphoma.
- Enrolled: 173 patients
- PMID 8365932 -- Accelerated hyperfractionated hepatic irradiation in the management of patients with liver metastases: results of the RTOG dose escalating protocol. (Russel AH, Int J Radiat Oncol Biol Phys. 1993 Sep 1;27(1):117-23.) Conclusion: "The study design could not credibly establish a safe dose for hepatic irradiation, however, it did succeed in determining that 33 Gy in fractions of 1.5 Gy is unsafe, carrying a substantial risk of delayed radiation injury. The absence of apparent late liver injury at the 27 Gy and 30 Gy dose levels suggests that a prior clinical trial of adjuvant hepatic irradiation in patients with resected colon cancer may have employed an insufficient radiation dose (21 Gy) to fully test the question."