계명대학교 의학도서관 Repository

Total neoadjuvant therapy with short-course radiotherapy Versus long-course neoadjuvant chemoradiotherapy in Locally Advanced Rectal cancer, Korean trial (TV-LARK trial): study protocol of a multicentre randomized controlled trial

Metadata Downloads
Author(s)
Min Jung KimDae Won LeeHyun-Cheol KangJi Won ParkSeung-Bum RyooSae-Won HanKyung Su KimEui Kyu ChieJae Hwan OhWoon Kyung JeongByoung Hyuck KimEun Mi NamSeung-Yong Jeong
Keimyung Author(s)
Jeong, Woon Kyung
Department
Dept. of Surgery (외과학)
Journal Title
BMC Cancer
Issued Date
2023
Volume
23
Issue
1
Keyword
ChemoradiotherapyChemotherapyPathologic complete responseRadiotherapyRectal cancerTotal neoadjuvant therapy
Abstract
Background:
For locally advanced rectal cancer (LARC), total neoadjuvant therapy (TNT) may enhance tumour response, reduce recurrence, and improve patient compliance compared to upfront surgery. Recent studies have shown that chemoradiotherapy (CRT) followed by consolidation chemotherapy leads to higher rate of pathologic complete response (pCR) than induction chemotherapy followed by CRT. However, an optimal TNT regimen that maximise the pCR rate and minimise toxicity has not been established. Therefore, the aim of this trial was to investigate whether preoperative short-course radiotherapy followed by chemotherapy with four cycles of CAPOX can double the pCR rate compared to a standard schedule of long-course preoperative CRT in patients with LARC.

Methods:
This is a multi-centre, prospective, open label, randomised controlled trial. Patients with clinical primary tumour stage 3 and higher or regional node-involved rectal cancer located within 10 cm from the anal verge were randomly assigned equally to short-course radiotherapy (25 Gy in 5 fractions over 1 week) followed by four cycles of CAPOX (intravenous oxaliplatin [130 mg/m2, once a day] on day 1 and capecitabine [1,000 mg/m2, twice a day] from days 1 to 14) (TNT) or CRT (50.4 Gy in 28 fractions over 5 weeks, concurrently with concomitant oral capecitabine 825 mg/m2 twice a day). After preoperative treatment, total mesorectal excision was performed 2-4 weeks in the TNT group and 6-10 weeks in the CRT group, followed by optional additional adjuvant chemotherapy. The primary endpoint is the pCR rate, and secondary endpoints include disease-related treatment failure, quality of life, and cost-effectiveness. Assuming a pCR rate of 28% and 15% in the TNT and CRT groups, respectively, and one-side alpha error rate of 0.025 and power of 80%, 348 patients will be enrolled considering 10% dropout rate.

Discussion:
The TV-LARK trial will evaluate the superiority of employed TNT regimen against the standard CRT regimen for patients with LARC. We aimed to identify a TNT regimen that will improve the pCR rate and decrease systemic recurrence in these patients.

Trial registration:
Cris.nih.go.kr ID: KCT0007169 (April 08, 2022). The posted information will be updated as needed to reflect the protocol amendments and study progress.
Keimyung Author(s)(Kor)
정운경
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1471-2407
Source
https://bmccancer.biomedcentral.com/articles/10.1186/s12885-023-11177-7
DOI
10.1186/s12885-023-11177-7
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45178
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
공개 및 라이선스
  • 공개 구분공개
파일 목록

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.