A randomized comparative study between neoadjuvant 5-fluorouracil and leukovorin versus 5-fluorouracil and cisplatin along with concurrent radiation in locally advanced carcinoma rectum

Context: Concurrent chemoradiotherapy (CCRT) with cisplatin-5-fluorouracil (CDDP-5FU) in rectal cancer is based on the concept of biochemical modulation. Aims: The study was designed to evaluate whether CCRT with CDDP and 5-FU is noninferior to CCRT with leukovorin (LV) and 5FU in downstaging locally advanced rectal adenocarcinoma and to compare the toxicities between the two arms. Settings and Design : Single institutional, noninferiority, prospective, randomized study. Subjects and Methods : In control arm (N = 24) patients received chemotherapy. With bolus 5FU 350 mg/m ² /day and LV 20 mg/m ² /day for days 1-5 and 29-33. In study arm (N = 25), patients received chemotherapy with bolus 5 FU 350 mg/m ² /day for days 1-5 and 29-33 and CDDP 100 mg/m ² /day at days 1 and 29. Patients in both the arm received concurrent radiation (50.4 Gy in 28#, in conventional fractionation of 1.8 Gy per fraction). Six to eight weeks after concurrent chemoradiation patients underwent assessment and surgery. Postoperatively, adjuvant chemotherapy with m-FOLFO × 6 of 4 months was given to all patients. Statistical Analysis : The Chi-square test was used to compare categorical variables between the groups. Results: Response rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST criteria) was comparable between the two treatment arms (P = 0.9541). Pathological complete response rate of study arm was comparable to control arm (20 vs 20.83%, P = 0.7778 was not significant). Surgery with R0 resection was possible in 72% cases of study arm compared to 62.5% cases of control arm; P = 0.6861, not significant. Grade III toxicities were quite comparable between two treatment arms. Conclusions : In terms of pathologic complete response (pCR), R0 resection and toxicity profile of both the arms were comparable.