Details

Autor(en) / Beteiligte

• 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

Titel

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

Ist Teil von

• The lancet oncology, 2014-06, Vol.15 (7), p.767-774

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2014

Quelle

MEDLINE

Beschreibungen/Notizen

• 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<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.