PHASE-I II TRIAL OF ACCELERATED FRACTIONATION IN BRAIN METASTASES RTOG 85-28/

Purpose: Radiation Therapy Oncology Group 85-28 represents a Phase I/I I trial of accelerated fractionation in patients with brain metastases . Methods and Materials: Patients entered had controlled or absent pri mary with metastases other than brain which were stable or only brain metastases with the primary uncontrolled. Karnosfky status was require d to be greater than 60. Patients received 1.6 Gy twice daily separate d by 4-8 hr delivered 5 days a week. The entire brain was treated to 3 2.0 Gy and the boost dose escalated from 16.0 Gy to 22.40 Gy and subse quently 32.00 Gy and 42.40 Gy. Results: We observed no undue toxicity with escalating dose of irradiation. An incremental, although not stat istically significant improvement in survival was noted with escalatin g doses. Median survival ranged from 4.2 months to 6.4 months with esc alating dose of irradiation. Median survival also increased in patient s with controlled primary tumors, non-lung primaries and solitary meta stasis. Conclusion: The incremental improvement in survival in patient s with good prognostic factors appeared encouraging. The Radiation The rapy Oncology Group will test the 54.4 Gy study against 30 Gy in 2 wee ks in a Phase III trial based on the results of this trial.