Title: Phase I/II Study of Fractionated Hemibody Irradiation to Treat Osseous Metastases in Patients with Primaries of the Breast or Prostate
(1) Determine the hematologic and acute nonhematologic toxicity of fractionated hemibody irradiation in the treatment of osseous metastases in patients with primaries of the breast or prostate.
(2) Establish the maximum tolerated dose of fractionated hemibody irradiation in this patient population.
(3) Study the delay of new metastases and the progression of existing asymptomatic metastases as a function of the treatment field.
NCI_Protocol: Fractionated hemibody irradiation plus local-field irradiation with electron beams
30 Gy in 10 fraction followed by escalating doses of HBI (2.5 Gy/fx):
Arm 1: HBI 10.0 Gy
Arm 2: HBI 12.5 Gy
Arm 3: HBI 15.0 Gy
Arm 4: HBI 17.5 Gy
Arm 5: HBI 20.0 Gy
Eligibility:Primary breast or prostate CA, no spinal compression, pain/narcotic score 2
Enrolled: 144 patients
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 CW, 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."
Scarantino C, Caplan R, Rotman M, et al.: A phase I/II study to evalutate the effect of fractionated hemibody irradiation in the treatment of osseous bone metastases-RTOG 88-22. Int J Radiat Oncol Biol Phys 32(suppl 1): A52, 167, 1995.