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Korean Society of Coloproctology (KSCP) trial of cONsolidation Chemotherapy for Locally advanced mid or low rectal cancer after neoadjUvant concurrent chemoraDiothErapy: a multicenter, randomized controlled trial (KONCLUDE)

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Author(s)
Chang Woo KimByung Mo KangIk Yong KimJi Yeon KimSun Jin ParkWon Cheol ParkKi Beom BaeByung-Noe BaeSeong Kyu BaekSeung Hyuk BaikGyung Mo SonYoon Suk LeeSuk-Hwan Lee
Keimyung Author(s)
Baek, Seong Kyu
Department
Dept. of Surgery (외과학)
Journal Title
BMC Cancer
Issued Date
2018
Volume
18
Issue
1
Keyword
ChemoradiotherapyConsolidation chemotherapyDisease free survivalPathologic complete responseRectal cancer
Abstract
BACKGROUND:

Neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision (TME) has been a standard treatment option for locally advanced rectal cancer with improved local control. However, systemic recurrence despite neoadjuvant CRT remained unchanged. The only significant prognostic factor proven to be important was pathologic complete response (pCR) after neoadjuvant CRT. Several efforts have been tried to improve survival of patients who treated with neoadjuvant CRT and to achieve more pCR including adding cytotoxic chemotherapeutic agents, chronologic modification of chemotherapy schedule or adding chemotherapy during the perioperative period. Consolidation chemotherapy is adding several cycles of chemotherapy between neoadjuvant CRT and TME. It could increase pCR rate, subsequently could show better oncologic outcomes.

METHODS:

Patients with advanced mid or low rectal cancer who received neoadjuvant CRT will be included after screening. They will be randomized and assigned to undergo TME followed by 8 cycles of adjuvant chemotherapy (control arm) or receive 3 cycles of consolidation chemotherapy before TME, and receive 5 cycles of adjuvant chemotherapy (experimental arm). The primary endpoints are pCR and 3-year disease-free survival (DFS), and the secondary endpoints are radiotherapy-related complications, R0 resection rate, tumor response rate, surgery-related morbidity, and peripheral neuropathy at 3 year after the surgery. The authors hypothesize that the experimental arm would show a 15% improvement in pCR (15 to 30%) and in 3-year DFS (65 to 80%), compared with the control arm. The accrual period is 2 years and the follow-up period is 3 years. Based on the superiority design, one-sided log-rank test with α-error of 0.025 and a power of 80% was conducted. Allowing for a drop-out rate of 10%, 358 patients (179 per arm) will need to be recruited. Patients will be followed up at every 3 months for 2 years and then every 6 months for 3 years after the last patient has been randomized.

DISCUSSION:

KONCLUDE trial aims to investigate whether consolidation chemotherapy shows better pCR and 3-year DFS than adjuvant chemotherapy alone for the patients who received neoadjuvant CRT for locally advanced rectal cancer. This trial is expected to provide evidence to support clear treatment guidelines for patients with locally advanced rectal cancer.
Keimyung Author(s)(Kor)
백성규
Publisher
School of Medicine (의과대학)
Citation
Chang Woo Kim et al. (2018). Korean Society of Coloproctology (KSCP) trial of cONsolidation Chemotherapy for Locally advanced mid or low rectal cancer after neoadjUvant concurrent chemoraDiothErapy: a multicenter, randomized controlled trial (KONCLUDE). BMC Cancer, 18(1), 538–538. doi: 10.1186/s12885-018-4466-7
Type
Article
ISSN
1471-2407
DOI
10.1186/s12885-018-4466-7
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41328
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
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