Radiotherapy alone with concurrent chemoradiotherapy plus temozolamide in locally advanced soft tissue sarcoma at Mayo Hospital Lahore: A randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of combining an oral chemotherapeutic agent temozolamide with radiotherapy in the management of the un-resectable non-metastatic soft tissue sarcomas compared with radiotherapy alone. METHODS: The randomised controlled phase 3, double-arm study was conducted at King Edward Medical University/Mayo Hospital, Lahore, Pakistan, from December 2012 to July 2017. Patients with all sub-types of locally advanced un-resectable soft tissue sarcomas were randomised into two groups. Group-A received radiotherapy alone while Group-B received concomitant chemoradiotherapy with temozolamide after receiving two cycles of standard chemotherapy. Response was evaluated according to response evaluation criteria in solid tumours through computed tomography scan or magnetic resonance imaging after 6 weeks following completion of radiotherapy. SPSS 21 was used for data analysis. RESULTS: Of the 64 patients, 32(50%) were assigned to each group. The mean age of Group-A was 36.25±20.31 and of Group-B 37.84±15.79 years .There were 18(56.3%) males in Group-A and 20(62.5%) in Group-B. Improvement in trends of overall response rate was observed in Group-B 24(75%) compared to 18(56.3%) in Group-A (p=0.12).. CONCLUSIONS: Though not statistically significant, there was improvement in response rate with the addition of temozolamide to standard radiation therapy.