Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial

Seung-Yong Jeong¹, Ji Won Park¹, Byung Ho Nam², Sohee Kim², Sung-Bum Kang³, Seok-Byung Lim⁴, Hyo Seong Choi⁵, Duck-Woo Kim³, Hee Jin Chang⁵, Dae Yong Kim⁵, Kyung Hae Jung⁶, Tae-You Kim⁷, Gyeong Hoon Kang⁸, Eui Kyu Chie⁹, Sun Young Kim⁵, Dae Kyung Sohn⁵, Dae-Hyun Kim⁵, Jae-Sung Kim¹⁰, Hye Seung Lee¹¹, Jee Hyun Kim¹², Jae Hwan Oh¹³

Affiliations

¹ Department of Surgery, Seoul National University College of Medicine, Colorectal Cancer Center, Seoul National University Cancer Hospital, Seoul, South Korea; Cancer Research Institute, Seoul National University, Seoul, South Korea.
² Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
³ Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
⁴ Department of Colon and Rectal Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
⁵ Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
⁶ Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
⁷ Division of Medical Oncology and Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
⁸ Department of Pathology, Seoul National University Hospital, Seoul, South Korea.
⁹ Department of Radiation Oncology, Seoul National University Hospital, Seoul, South Korea.
¹⁰ Department of Radiation Oncology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
¹¹ Department of Pathology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
¹² Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
¹³ Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea. Electronic address: jayoh@ncc.re.kr.

PMID: 24837215
DOI: 10.1016/S1470-2045(14)70205-0

Randomized Controlled Trial

Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial

Seung-Yong Jeong et al. Lancet Oncol. 2014 Jun.

. 2014 Jun;15(7):767-74.

doi: 10.1016/S1470-2045(14)70205-0. Epub 2014 May 15.

Authors

Affiliations

¹ Department of Surgery, Seoul National University College of Medicine, Colorectal Cancer Center, Seoul National University Cancer Hospital, Seoul, South Korea; Cancer Research Institute, Seoul National University, Seoul, South Korea.
² Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
³ Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
⁴ Department of Colon and Rectal Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
⁵ Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
⁶ Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
⁷ Division of Medical Oncology and Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
⁸ Department of Pathology, Seoul National University Hospital, Seoul, South Korea.
⁹ Department of Radiation Oncology, Seoul National University Hospital, Seoul, South Korea.
¹⁰ Department of Radiation Oncology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
¹¹ Department of Pathology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
¹² Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
¹³ Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea. Electronic address: jayoh@ncc.re.kr.

PMID: 24837215
DOI: 10.1016/S1470-2045(14)70205-0

Erratum in

Correction to Lancet Oncol 2014; 16: 767.
[No authors listed] [No authors listed] Lancet Oncol. 2016 Jul;17(7):e270. doi: 10.1016/S1470-2045(16)30218-2. Epub 2016 Jun 28. Lancet Oncol. 2016. PMID: 27733292 No abstract available.

Abstract

Background: Compared with open resection, laparoscopic resection of rectal cancers is associated with improved short-term outcomes, but high-level evidence showing similar long-term outcomes is scarce. We aimed to compare survival outcomes of laparoscopic surgery with open surgery for patients with mid-rectal or low-rectal cancer.

Methods: The Comparison of Open versus laparoscopic surgery for mid or low REctal cancer After Neoadjuvant chemoradiotherapy (COREAN) trial was an open-label, non-inferiority, randomised controlled trial done between April 4, 2006, and Aug 26, 2009, at three centres in Korea. Patients (aged 18-80 years) with cT3N0-2M0 mid-rectal or low-rectal cancer who had received preoperative chemoradiotherapy were randomly assigned (1:1) to receive either open or laparoscopic surgery. Randomisation was stratified by sex and preoperative chemotherapy regimen. Investigators were masked to the randomisation sequence; patients and clinicians were not masked to the treatment assignments. The primary endpoint was 3 year disease-free survival, with a non-inferiority margin of 15%. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00470951.

Findings: We randomly assigned 340 patients to receive either open surgery (n=170) or laparoscopic surgery (n=170). 3 year disease-free survival was 72·5% (95% CI 65·0-78·6) for the open surgery group and 79·2% (72·3-84·6) for the laparoscopic surgery group, with a difference that was lower than the prespecified non-inferiority margin (-6·7%, 95% CI -15·8 to 2·4; p<0·0001). 25 (15%) patients died in the open group and 20 (12%) died in the laparoscopic group. No deaths were treatment related.

Interpretation: Our results show that laparoscopic resection for locally advanced rectal cancer after preoperative chemoradiotherapy provides similar outcomes for disease-free survival as open resection, thus justifying its use.

Funding: National Cancer Center, South Korea.

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Comment in

Minimally-invasive approach for rectal cancer surgery.
Brouquet A, Nordlinger B. Brouquet A, et al. Lancet Oncol. 2014 Jun;15(7):680-1. doi: 10.1016/S1470-2045(14)70233-5. Epub 2014 May 15. Lancet Oncol. 2014. PMID: 24837214 No abstract available.
Gleiche Langzeitergebnisse mit laparoskopischem wie mit offenem Vorgehen beim Rektumkarzinom nach neoadjuvanter Radiochemotherapie möglich.
Hohenberger W. Hohenberger W. Strahlenther Onkol. 2014 Oct;190(10):965-6. doi: 10.1007/s00066-014-0748-4. Strahlenther Onkol. 2014. PMID: 25267207 German. No abstract available.
[Oncological long-term results after open versus laparoscopic surgery for rectal cancer].
Reibetanz J, Germer CT. Reibetanz J, et al. Chirurg. 2014 Dec;85(12):1113. doi: 10.1007/s00104-014-2911-y. Chirurg. 2014. PMID: 25424892 German. No abstract available.
[Some long-term results of laparoscopic resection after neoadjuvant chemotherapy in locally advanced rectal cancer as compared to conventional open surgery].
Hohenberger W. Hohenberger W. Strahlenther Onkol. 2015 Jan;191(1):76-7. doi: 10.1007/s00066-014-0773-3. Strahlenther Onkol. 2015. PMID: 25729793 German. No abstract available.

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Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial

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Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial

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