A prospective randomized trial comparing once-a-week vs daily radiation therapy for locally-advanced, non-metastatic, XXXX : a preliminary report.

@entity1 @entity137 @entity353 @entity5 @entity2910 @entity2
This is the first report of an on-going Phase III protocol for @entity1 with locally-advanced, non-metastatic, measurable @entity2 . The study randomizes two arms: 6000 rad using 500 rad fractions once a week (1 X W) for 12 weeks with spinal cord (SC) protection at 3000 rad; and 6000 rad using 200 rad fractions daily (5 X W) for 6 weeks with SC protection at 4500 rad. Both arms use an initially large loco-regional field that is further reduced when @entity5 doses reach 3000 rad in (1 X W) arm and 5000 rad in (5 X W) arm. The protocol was activated April 1982; as of August 1984, it had accrued 100 @entity1 of whom 68 were evaluable [29 (1 X W) and 39 (5 X W)]. There have been no major differences in @entity5 responses or failure patterns between the (1 X W) and (5 X W) arms; response rates have been 69 and 64%; CR 31 and 20%; total incidence of local failures 20 and 23%; and overall incidence of distant failures 34 and 43%, respectively. The (1 X W) arm has been far better tolerated with 76% of its @entity1 free of any @entity2910 and 97% without @entity353 , as compared to only 33 and 67% in the (5 X W), respectively. The (1 X W) arm has not conveyed loss in @entity5 control effectiveness, in-treatment progression, or higher incidence of distant spread. Subacute and chronic complications have been minimal with either treatment. No fatal or life-threatening @entity137 have occurred; the incidence of severe complications has been 7% in the (1 X W) arm and 8% in the (5 X W) arm. Nevertheless, the number of @entity1 alive and at risk greater than or equal to 12 months is still relatively small; definitive statements regarding very late toxic reactions cannot yet be made. Compared to their protocyptes [a (1 X W) Pilot Study and the 6000 rad/6 weeks arm of RTOG Protocol 73-01], results in the present protocol arms have not been different from what was expected. Once a week RT yields results that appear no different from those achieved with conventional RT in @entity2 .
