Randomized prospective clinical study of small, large and twice-a-day fraction radiotherapy for painful bone metastases.

A prospective randomized clinical trial comparing small, large and twice-a-day fraction for the relief of painful bone metastases was performed from 1981 to 1986 at Tokyo Women's Medical College Hospital. Eighty patients with painful bone metastases (92 sites) were divided into three radiation methods which were conventional fraction scheme of 5 times/week at 2 Gy/day for a total of 30 Gy/15 fractions (Group I, TDF: 49), 2 times/week at 4.5 Gy/day for a total of 22.5 Gy/5 fractions (Group II, TDF: 50) and 3 times/week at 2 Gy/day twice a day at a minimum interval of 6 h for a total of 20 Gy/10 fractions (Group III). Pain was assessed using a score and response rate was 76% in Group I, 75% in Group II and 78% in Group III which were not statistically significant mutually. Group II and III regimes were found to have an earlier shorter onset of pain relief than Group I, but the dose of onset of pain relief was almost the same. Our data suggested that individualization of radiotherapy schedules based on to assess the patient's condition and the expected quality of life and to consider radiation site and size of field, was more important than the fractionation regime in the treatment of painful bone metastases.