Quality of Life Analysis of a Phase II randomised controlled trial comparing 3D-Conformal Radiotherapy and Intensity Modulated Radiotherapy in Locally Advanced Rectal Cancer (TRI-LARC)

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BackgroundNeoadjuvant radiotherapy is an integral part of the management of locally advanced rectal cancer. Radiotherapy can be delivered using 3DCRT and IMRT techniques. We herein compare the quality of life (QOL) outcomes of patients who received radiotherapy using these techniques in a randomised trial. MethodsA phase II randomised trial was conducted in patients with locally advanced rectal cancer. Patients staged as T3-4, N (any) or circumferential resection margin at risk were eligible. All patients underwent neoadjuvant chemoradiotherapy with 50.4Gy given in 28 fractions with concomitant Fluorouracil or Capecitabine. Patients were randomly allocated, in a 1:1 ratio, to 3DCRT or IMRT planning techniques. QOL, a secondary objective of the study, was evaluated using the EORTC QLQ C30 and QLQ CR29 questionnaires at baseline, during the final week of radiotherapy and six months after radiotherapy. The impact of the treatment arm on QOL scores were evaluated using analysis of covariance, after adjusting for the pre-intervention scores. Results94 patients were accrued between October 2014 and March 2020. The trial was terminated early due to futility of the primary outcome, acute gastrointestinal toxicity, at interim analysis. 86(91%) patients completed the baseline questionnaire and one other time point of assessment. Median follow-up was 1.9years. Overall, both during the final week of radiotherapy and at six months, emotional functioning had improved but physical, role and social functioning had declined compared to baseline. At baseline, there was no difference in QOL scores between the two arms. During the final week of radiotherapy, the IMRT arm was associated with better adjusted mean physical (p=0.04) and role functioning (p=0.01) scores. ConclusionIMRT is associated with limited QOL benefits compared to 3DCRT in patients undergoing neoadjuvant chemoradiotherapy for locally advanced rectal cancer.