Randomized phase I study of standard-fractionated or accelerated-hyperfractionated radiotherapy with concurrent @entity900 and XXXX for unresectable @entity1149 : a report of Japan Clinical Oncology Group Study (JCOG 9601).

@entity1 @entity137 @entity7324 @entity417 @entity882 @entity2910 @entity648 @entity1149 @entity900 @entity519 @entity1207 @entity1431
BACKGROUND: We attempted dose escalation of standard-fractionated and accelerated-hyperfractionated radiotherapy combined with concurrent @entity900 and @entity7324 to improve local control and survival in unresectable @entity1149 . METHODS: Twenty-one @entity1 were enrolled between June 1996 and August 1997. There were 19 males and two females and their median age was 65 years (range 45-74 years). Performance status was 0 in 10 cases and 1 in 11 cases. Disease stage was IIIA in three cases and IIIB in 18 cases. The cases were randomized to a standard-fractionated arm (n = 10) or an accelerated-hyperfractionated radiotherapy arm (n = 11) with two or three cycles of concomitant @entity900 80 mg/m(2) on day 1 and @entity7324 3 mg/m(2) on days 1 and 8 every 4 weeks in both arms. Dose escalation from 60 Gy/30 fractions/6 weeks to 70 Gy/35 fractions/7 weeks was planned in the standard-fractionated radiotherapy group and from 54 Gy/36 fractions/3.6 weeks to 60 Gy/40 fractions/4 weeks and then 66 Gy/44 fractions/4.4 weeks in the accelerated-hyperfractionated radiotherapy group. RESULTS: Grade 3 or 4 hematological @entity137 were observed as follows: in the standard-fractionated/accelerated-hyperfractionated radiotherapy group, @entity1431 9/10, @entity417 2/3 and @entity882 0/2. Grade 3 non-hematological @entity137 consisted of @entity2910 0/3, increased serum total @entity648 2/0 and @entity519 0/1. Two @entity1 died of @entity1207 in the standard-fractionated radiotherapy group. Dose-limiting @entity137 was observed in four of the 10 and seven of the 11 @entity1 at initial dose level of standard-fractionated radiotherapy, 60 Gy/30 fractions/6 weeks, and of accelerated-hyperfractionated radiotherapy, 54 Gy/36 fractions/3.6 weeks, respectively. Thus, we failed to escalate the dose of radiotherapy in both arms. The overall response rate in the standard-fractionated group and the accelerated-hyperfractionated radiotherapy group was 70 and 73% and the 1-year survival rate was 70 and 64%, respectively. CONCLUSIONS: We concluded that these schedules of radiotherapy with concurrent @entity900 and @entity7324 were unacceptable for use in @entity1 with unresectable @entity1149 . Further modifications of the schedule for radiotherapy and evaluation of combination with new chemotherapy are warranted.
