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

• Published in: The lancet oncology 2014-06, Vol.15 (7), p.767-774
• Main Authors: Jeong, Seung-Yong, Prof, Park, Ji Won, MD, Nam, Byung Ho, Prof, Kim, Sohee, MS, Kang, Sung-Bum, MD, Lim, Seok-Byung, MD, Choi, Hyo Seong, MD, Kim, Duck-Woo, MD, Chang, Hee Jin, MD, Kim, Dae Yong, MD, Jung, Kyung Hae, Prof, Kim, Tae-You, Prof, Kang, Gyeong Hoon, Prof, Chie, Eui Kyu, MD, Kim, Sun Young, MD, Sohn, Dae Kyung, MD, Kim, Dae-Hyun, MD, Kim, Jae-Sung, Prof, Lee, Hye Seung, MD, Kim, Jee Hyun, MD, Oh, Jae Hwan, Prof
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Chemoradiotherapy; Chemotherapy; Classification; Colorectal cancer; Female; Hematology, Oncology and Palliative Medicine; Humans; Laparoscopy; Male; Medical treatment; Middle Aged; Neoadjuvant Therapy; Rectal Neoplasms - mortality; Rectal Neoplasms - therapy; Surgery; Treatment Outcome
• ISSN: 1470-2045; 1474-5488
• DOI: 10.1016/S1470-2045(14)70205-0

Summary 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