Radiation Oncology/RTOG Trials/8206

RTOG 82-06 (PALLIATION)
 * Title: Phase III Comparison of Local Field Irradiation with and without Single-Dose Hemibody Irradiation for Control of Symptomatic Bony Metastases
 * Objectives:
 * (1) Determine whether the addition of a single dose of hemibody irradiation to standard fractionated local field irradiation has a beneficial effect in terms of delaying the development of new metastases and delaying the progression of existing asymptomatic metastases in cancer patients with painful osseous metastases.
 * (2) Assess tumor response by evaluation of measurable lesions in different sites in patients treated with local field irradiation vs. local field plus hemibody irradiation.
 * (3) Document the morbidity of hemibody irradiation added to a standard fractionated therapy schedule.
 * NCI_Protocol:
 * Arm 1: 30 Gy
 * Arm 2: 30 Gy + 8 Gy hemibody irradiation
 * Enrolled: 499 patients
 * Conclusion:
 * PMID 1374061 -- A report of RTOG 8206: a phase III study of whether the addition of single dose hemibody irradiation to standard fractionated local field irradiation is more effective than local field irradiation alone in the treatment of symptomatic osseous metastases. (Poulter CA, IJRBOP 1992). Conclusion: This clinical trial demonstrates that HBI has the potential to be used to treat systemic and occult metastases, particularly if both halves of the body can be treated.
 * Publications:
 * PMID 8823257 -- A phase I/II study to evaluate the effect of fractionated hemibody irradiation in the treatment of osseous metastases--RTOG 88-22. (Scarantino, IJRBOP 1996). Conclusion: "The maximum tolerated dose of fractionated (2.50 Gy) HBI was found to be 17.5 Gy. The major dose limiting toxicity was hematological (thromboleukopenia). There was not a significant dose response effect on occult disease (appearance of new disease) or in the requirement for additional treatment, although certain trends were noted for the higher doses. When only patients completing assigned HBI from RTOG 82-06 and 88-22 were compared, there was no difference in the time to new disease or additional treatment in the treated field. Based on the investigative parameters of this study, single high-dose HBI was as effective as fractionated HBI. The incorporation of cytokines, to ameliorate hematological toxicity, should allow for the delivery of higher doses of fractionated HBI and sequential HBI as a means of delivering systemic irradiation."
 * PMID 7679040 -- Irradiation in relapsing carcinoma of the prostate. (Perez CA, Cancer 1993). Review. Conclusion: The role of irradiation in the treatment of spinal cord compression is discussed. Significant improvement of neurologic function has been reported in 36-60% of the patients, depending on severity of deficit and promptness in instituting emergency treatment.
 * Poulter, C., Cosmatos, D., Rubin, P., Urtasun, R., Cooper, J., Kuske, R., Hornback, N., Coughlin, C., Weigensberg, I. and Rotman, M.: A Report of RTOG 82-06: A Phase III Study of Whether the Addition of Single Dose Hemibody Irradiation to Standard Fractionated Local Field Irradiation is More Effective Than Local Field Irradiation Alone in the Treatment of Symptomatic Osseous Mets. Int J Radiat Oncol Biol Phys, 23(1):207-214, 1992.