RTOG 80-03 (LIVER)
Title: Phase III Comparison of Radiation Alone vs Radiation plus Misonidazole in the Treatment of Liver Metastases
I. Compare the frequency and duration of symptomatic relief in patients with liver metastases from a variety of sites treated by radiotherapy alone vs. radiotherapy plus misonidazole.
II. Compare the frequency and duration of normalization of liver function in these 2 groups.
III. Compare the frequency of decrease in the size of liver metastases by CT scans in the 2 groups.
IV. Evaluate the response for each treatment according to site and histology of the primary, performance status, and tumor volume.
V. Evaluate the foregoing objective with respect to the length of survival.
Arm 1: RT (whole liver to a dose of 21.0 Gy in 3 Gy/fx)
Arm 2: RT + radiosensitization with Misonidazole
Eligibility: Patients with histologic verification of malignancy other than leukemia, myeloma, or lymphoma, and with hepatic metastases as documented by liver scan and/or CT scan.
Enrolled: 214 patients
PMID 3597149 -- A comparison of misonidazole sensitized radiation therapy to radiation therapy alone for the palliation of hepatic metastases: results of a Radiation Therapy Oncology Group randomized prospective trial. (Leibel SA, Int J Radiat Oncol Biol Phys. 1987 Jul;13(7):1057-64.) Conclusion: "The addition of misonidazole did not significantly improve the therapeutic response to radiation therapy in any of the parameters studied."
PMID 2180867 -- Accelerated fractionation radiation therapy for liver metastases: selection of an optimal patient population for the evaluation of late hepatic injury in RTOG studies. (Leibel SA, Int J Radiat Oncol Biol Phys. 1990 Mar;18(3):523-8. Conclusion: Favorable characteristics: KPS >=80, CRC primary, no extrahepatic mets