Background: The most common neoadjuvant therapy for locally advanced rectal cancer is fluoropyrimidine-based chemotherapy combined with radiation (45-50.4 Gy) (LARC). Recently many studies focusing on shifting systemic chemotherapy to preoperative setting to increase pathological complete response rate (pCR).Patients & Methods: This is a randomized controlled trial (RCT) of stage II-III rectal cancer patients treated from October 2020 to April 2022. They were randomized into: Experimental group: Total neoadjuvant therapy (TNT) with short course radiotherapy (25 Gy) then chemotherapy (Capecitabine and Oxaliplatin) for 6 cycles followed by total mesorectal excision (TME). Control group: Standard long course concurrent chemo radiotherapy (LC-CCRT, 45-50.4Gy) with Capecitabine followed by TME and adjuvant chemotherapy. Primary end points were pathological complete response (pCR) and disease related treatment failure (DrTF). Secondary end points were restricted mean survival time at 12 months (RMST), toxicity and surgical complications. Results: High risk criteria as N2 and infiltrated mesorectal fascia (MRF) were statistically higher in TNT group (p=0.005, p= 0.04 respectively). Complete response was achieved radiologically in 11.5% and pathologically in 33.3 % exclusively in TNT group. Restricted mean survival time (RMST) at 12 months was 11.6 months in TNT group and 11.1 months in control group. Pathological complete response was statistically correlated to improvement in DrTF and RMST at 12 months (p =0.01). Conclusion: Short course radiotherapy with neoadjuvant chemotherapy is a good alternative to the standard LC-CCRT with less hospital treatment days and cost especially after COVID 19 pandemic.
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