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An official publication of the Middle-Eastern Association for Cancer Research
Clinical Cancer Investigation Journal
ISSN Print: 2278-1668, Online: 2278-0513
ARTICLE
Year: 2014   |   Volume: 3   |   Issue: 1   |   Page: 32-37     View issue

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


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Abstract

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.

Cite this article
Vancouver
Kayal P, Saha A, Dastidar A, Mahata A, Das A, Sarkar R. A randomized comparative study between neoadjuvant 5-fluorouracil and leukovorin versus 5-fluorouracil and cisplatin along with concurrent radiation in locally advanced carcinoma rectum. Clin Cancer Investig J. 2014;3(1):32-7. https://doi.org/10.4103/2278-0513.125791
APA
Kayal, P., Saha, A., Dastidar, A., Mahata, A., Das, A., & Sarkar, R. (2014). A randomized comparative study between neoadjuvant 5-fluorouracil and leukovorin versus 5-fluorouracil and cisplatin along with concurrent radiation in locally advanced carcinoma rectum. Clinical Cancer Investigation Journal, 3(1), 32-37. https://doi.org/10.4103/2278-0513.125791

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ISSN Print: 2278-1668, Online: 2278-0513