Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection compared with standard gastrectomy with lymphadenectomy in early gastric cancer: A study protocol of a multicenter randomized phase III clinical trial (SENORITA trial).

Authors

null

Keun Won Ryu

National Cancer Center, Goyang, South Korea

Keun Won Ryu , Ji Yeon Park , Young Woo Kim , Byung-Ho Nam , Young Joon Lee , Sang-Ho Jeong , Ji-Ho Park , Hoon Hur , Sang Uk Han , Jae-Seok Min , Ji Yeong An , Woo Jin Hyung , Gyu Seok Cho , Gui Ae Jeong , Oh Jeong , Young-Kyu Park , Mi Ran Jung , Hong Man Yoon , Bang Wool Eom

Organizations

National Cancer Center, Goyang, South Korea, Gyeongsang National University College of Medicine, Jinju, South Korea, Gyengsang National University College of Medicine, Jinju, South Korea, Ajou University School of Medicine, Suwon, South Korea, Dongnam Institute of Radiological and Medical Science, Busan, South Korea, Yonsei University College of Medicine, Seoul, South Korea, Soonchunhyang University College of Medicine, Bucheon, South Korea, Chonnam National University Medical School, Hwasun, South Korea, Chonnam National University Hwasun Hospital, Hwasun, South Korea

Research Funding

Other

Background: Along with marked increase in early gastric cancer (EGC) in Eastern countries, there has been an effort to adopt sentinel node concept in EGC to reduce immediate postoperative complications and preserve gastric function. Based on the promising results from the previous quality control study prior to phase III trial, this prospective multicenter randomized controlled trial aimed to elucidate the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection (SBD) compared to standard laparoscopic gastrectomy. Methods: This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with non-inferiority design. Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma with a diameter of 3cm or less are eligible for the present study. A total of 580 patients (290 per each group) will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival (DFS) and the secondary endpoints include postoperative morbidity and mortality, quality of life, and 5-year DFS and overall survival. The qualified investigators who completed the prior quality control study are exclusively allowed to participate in this phase III clinical trial. Discussion: The proposed trial is expected to verify whether laparoscopic stomach-preserving surgery with SBD achieves the similar oncologic outcomes and improved quality of life compared to the standard gastrectomy in EGC patients. Clinical trial information: NCT01804998

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2016 Gastrointestinal Cancers Symposium

Session Type

Trials in Progress Poster Session

Session Title

Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach

Track

Cancers of the Esophagus and Stomach

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT01804998

Citation

J Clin Oncol 34, 2016 (suppl 4S; abstr TPS179)

DOI

10.1200/jco.2016.34.4_suppl.tps179

Abstract #

TPS179

Poster Bd #

O5

Abstract Disclosures