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BMC Cancer. 2018 May 8;18(1):538. doi: 10.1186/s12885-018-4466-7.

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).

Author information

1
Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892 Dongnam-ro, Gangdong-gu, Seoul, 05278, South Korea.
2
Department of Medicine, the Graduate School of Yonsei University, 50-1 Yonsei-ro, Seoul, South Korea.
3
Department of Surgery, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, 77 Sakju-ro, Chuncheon, South Korea.
4
Department of Surgery, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, South Korea.
5
Department of Surgery, Chungnam National University Hospital, Chungnam National University College of Medicine, 282 Munhwa-ro, Daejeon, South Korea.
6
Department of Surgery, Kyung Hee Medical Center, Kyung Hee University School of Medicine, 23 Kyung Hee dae-ro, Seoul, South Korea.
7
Department of Surgery, Wonkwang University Hospital, Wonkwang University School of Medicine, 895 Muwang-ro, Iksan, South Korea.
8
Department of Surgery, Inje University Busan Paik Hospital, Inje University College of Medicine, 75 Bokji-ro, Busan, South Korea.
9
Department of Surgery, Inje University Sanggye Paik Hospital, Inje University College of Medicine, 1342 Dongil-ro, Seoul, South Korea.
10
Department of Surgery, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, 56 Dalseong-ro, Daegu, South Korea.
11
Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Seoul, South Korea.
12
Department of Surgery, Pusan National University Yangsan Hospital, Pusan University College of Medicine, 20 Geumo-ro, Yangsan-si, South Korea.
13
Department of Surgery, Seoul St. Mary's Hospital, The Catholic University College of Medicine, 222 Banpodae-ro, Seoul, South Korea.
14
Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892 Dongnam-ro, Gangdong-gu, Seoul, 05278, South Korea. leeshdr@gmail.com.

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.

TRIAL REGISTRATION:

Clinicaltrials.gov NCT02843191 (First posted on July 25, 2016).

KEYWORDS:

Chemoradiotherapy; Consolidation chemotherapy; Disease free survival; Pathologic complete response; Rectal cancer

PMID:
29739356
PMCID:
PMC5941462
DOI:
10.1186/s12885-018-4466-7
[Indexed for MEDLINE]
Free PMC Article

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