Radiation Oncology/RTOG Trials/8003

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RTOG 80-03 (LIVER)

  • Title: Phase III Comparison of Radiation Alone vs Radiation plus Misonidazole in the Treatment of Liver Metastases
  • Objective:
    • 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.
  • Protocol:
    • 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
  • Conclusion:
    • 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."
  • Publications:
    • 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