Radiotherapy in the management of locally advanced lung cancer of all cell types: final report of randomized trial.

Between 1975 and 1978, 343 evaluable male patients with a diagnosis of locally advanced lung cancer of all cell types were entered in Protocol 15. The patients had unresectable or inoperable tumor limited to one hemithorax and no evidence of distant metastases. The cell-type distribution was as follows: squamous cell carcinoma (Sq CC) 137 (40%); positive cytology 66 (19%); large cell carcinoma 57 (17%); small cell carcinoma (SCC) 46 (13%) and adenocarcinoma 37 (11%). An intermediate course of irradiation (ICI) of 5000 rads in 25 fractions, 200 rads each, in 5 weeks was compared with a short course of irradiation (SCI) of 4200 rads in 15 fractions, 280 rads each, in 3 weeks (equal Nominal Standard Dose). The effectiveness of low dose irradiation to control subclinical brain metastases was studied and was reported separately. The median survival for all 343 patients was 38 weeks. There was no significant difference in survival, response and control rate between the 191 ICI and the 152 SCI patients. The following factors had a significant individual influence on survival: initial performance status, ambulatory vs. nonambulatory, P = 0.006; histology, Sq CC vs. other cell types (OCT), P = 0.0007; prior surgery, less than 6 weeks vs. greater than 6 weeks, p = 0.04; tumor size, diameter less than 6 cm vs. greater than 6 cm, P = 0.05 and weight loss less than 5% vs. greater than 5% in the previous 6 months, P = 0.01. The overall response rate (CR or PR) was 38%. The median duration of response was shorter for the ICI group when compared with the SCI group, 18.4 vs. 34.4 weeks, P = 0.02. The presence of partial or complete response enhanced the median survival 50 vs. 31 weeks. Cell type, Sq CC vs. OCT was an important factor for the duration of response, 49 vs. 21 weeks, P = 0.0006. The complication rate was similar for the 191 ICI patients when compared with the 152 SCI patients. There were however, two patients with radiation myelopathy among the SCI patients and none among the ICI patients.

RCT Entities:   Population Interventions Outcomes