Laparoscopic or Open Distal Gastrectomy After Neoadjuvant Chemotherapy for Advanced Gastric Cancer: Study Protocol for a Randomised Phase II Trial

Overview

Journal BMJ Open

Specialty General Medicine

Date 2018 Aug 13

PMID 30099396

Citations 5

Authors

Ziyu Li

Fei Shan

Xiangji Ying

Lianhai Zhang

Hui Ren

Shuangxi Li

Yongning Jia

Rulin Miao

Kan Xue

Zhemin Li

Yinkui Wang

Chao Yan

Yan Zhang

Fei Pang

Jiafu Ji

Affiliations

Soon will be listed here.

Abstract

Introduction: Current guidelines recommend open gastrectomy with D2 lymph node dissection and adjuvant chemotherapy as the standard treatment for advanced gastric cancer. However, the prognosis is not satisfactory. Perioperative chemotherapy has been proposed to improve survival. Although still in debate, the efficacy of laparoscopic distal gastrectomy (LDG) in patients with advanced gastric cancer has been demonstrated in a few trials. Therefore, LDG after neoadjuvant chemotherapy can be a candidate for future standard treatment on advanced distal gastric cancer. We propose a randomised phase II trial to compare LDG and open distal gastrectomy (ODG) after neoadjuvant chemotherapy for advanced gastric cancer.

Methods And Analysis: To test the efficacy and safety, a randomised, open-label, single-centre, phase II trial was designed to evaluate the non-inferiority of LDG compared with ODG after neoadjuvant chemotherapy, with 3-year recurrence-free survival as the primary endpoint. The chosen critical value of a non-inferiority margin was an increase of <8%. The study started in 2015 and enrolled 96 patients according to a prior sample size calculation. Intention-to-treat and per-protocol approach will be used for efficacy analysis, and as-treated analysis will be applied for safety analysis. The survival curves will be constructed as time-to-event plots using the Kaplan-Meier method and compared using log-rank tests and Cox proportional hazards model. All statistical analyses will be conducted in standard statistical software with a significance level of 0.05.

Ethics And Dissemination: This study was approved by the Peking University Cancer Hospital Ethics Committee. The results will be submitted for publication in peer-reviewed journals.

Trial Registration Number: NCT02404753; Pre-results.

Citing Articles

Current clinical trials on gastric cancer surgery in China.

Zhang S, Hu R, Cui X, Song C, Jiang X World J Gastrointest Oncol. 2024; 16(11):4369-4382.

PMID: 39554743 PMC: 11551648. DOI: 10.4251/wjgo.v16.i11.4369.

Short-term outcomes of laparoscopic versus open proximal gastrectomy with double-tract reconstruction for Siewert type II and III adenocarcinoma of the esophagogastric junction: a retrospective observational study of consecutive patients.

Ma F, Wang W, Guo D, Zhang Y, Peng L, Ma Q Ann Transl Med. 2021; 9(4):352.

PMID: 33708979 PMC: 7944316. DOI: 10.21037/atm-21-130.

FLOT Neoadjuvant Chemotherapy Followed by Laparoscopic D2 Gastrectomy in the Treatment of Locally Resectable Advanced Gastric Cancer.

Zhang S, Yan D, Sun Q, Du T, Cao D, Yang Y Can J Gastroenterol Hepatol. 2020; 2020:1702823.

PMID: 32566545 PMC: 7277051. DOI: 10.1155/2020/1702823.

Assessment of Laparoscopic Distal Gastrectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Clinical Trial.

Li Z, Shan F, Ying X, Zhang Y, E J, Wang Y JAMA Surg. 2019; 154(12):1093-1101.

PMID: 31553463 PMC: 6763995. DOI: 10.1001/jamasurg.2019.3473.

Laparoscopic versus open gastrectomy for elderly local advanced gastric cancer patients: study protocol of a phase II randomized controlled trial.

Li Z, Shan F, Ying X, Xue K, Ji J BMC Cancer. 2018; 18(1):1118.

PMID: 30445943 PMC: 6240197. DOI: 10.1186/s12885-018-5041-y.

References

Qiu J, Pankaj P, Jiang H, Zeng Y, Wu H . Laparoscopy versus open distal gastrectomy for advanced gastric cancer: a systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech. 2013; 23(1):1-7. DOI: 10.1097/SLE.0b013e3182747af7. View

Neuenschwander B, Rouyrre N, Hollaender N, Zuber E, Branson M . A proof of concept phase II non-inferiority criterion. Stat Med. 2011; 30(13):1618-27. DOI: 10.1002/sim.3997. View

Hu Y, Huang C, Sun Y, Su X, Cao H, Hu J . Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016; 34(12):1350-7. DOI: 10.1200/JCO.2015.63.7215. View

Clavien P, Sanabria J, Strasberg S . Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992; 111(5):518-26. View

Cheng J, Liu B, Zhang X, Zhang Y, Lin W, Wang R . The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol. 2011; 11:56. PMC: 3112193. DOI: 10.1186/1471-2288-11-56. View

Xiong B, Cheng Y, Ma L, Zhang C . An updated meta-analysis of randomized controlled trial assessing the effect of neoadjuvant chemotherapy in advanced gastric cancer. Cancer Invest. 2014; 32(6):272-84. DOI: 10.3109/07357907.2014.911877. View

Cai J, Wei D, Gao C, Zhang C, Zhang H, Zhao T . A prospective randomized study comparing open versus laparoscopy-assisted D2 radical gastrectomy in advanced gastric cancer. Dig Surg. 2011; 28(5-6):331-7. DOI: 10.1159/000330782. View

Li Z, Shan F, Wang Y, Li S, Jia Y, Zhang L . Laparoscopic versus open distal gastrectomy for locally advanced gastric cancer after neoadjuvant chemotherapy: safety and short-term oncologic results. Surg Endosc. 2016; 30(10):4265-71. DOI: 10.1007/s00464-015-4739-z. View

An J, Kim K, Kim Y, Cheong J, Hyung W, Noh S . Surgical complications in gastric cancer patients preoperatively treated with chemotherapy: their risk factors and clinical relevance. Ann Surg Oncol. 2012; 19(8):2452-8. DOI: 10.1245/s10434-012-2267-9. View

10.

Yoshikawa T, Fukunaga T, Taguri M, Kunisaki C, Sakuramoto S, Ito S . Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for operable gastric cancer, a randomized Phase II trial (LANDSCOPE trial). Jpn J Clin Oncol. 2012; 42(7):654-7. DOI: 10.1093/jjco/hys057. View

11.

Downie W, Leatham P, Rhind V, WRIGHT V, Branco J, ANDERSON J . Studies with pain rating scales. Ann Rheum Dis. 1978; 37(4):378-81. PMC: 1000250. DOI: 10.1136/ard.37.4.378. View

12.

Cunningham D, Allum W, Stenning S, Thompson J, van de Velde C, Nicolson M . Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006; 355(1):11-20. DOI: 10.1056/NEJMoa055531. View

13.

Hjermstad M, Fayers P, Haugen D, Caraceni A, Hanks G, Loge J . Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011; 41(6):1073-93. DOI: 10.1016/j.jpainsymman.2010.08.016. View

14.

Eisenhauer E, Therasse P, Bogaerts J, Schwartz L, Sargent D, Ford R . New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2008; 45(2):228-47. DOI: 10.1016/j.ejca.2008.10.026. View

15.

Hudis C, Barlow W, Costantino J, Gray R, Pritchard K, Chapman J . Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007; 25(15):2127-32. DOI: 10.1200/JCO.2006.10.3523. View

16.

. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2016; 20(1):1-19. PMC: 5215069. DOI: 10.1007/s10120-016-0622-4. View

17.

. Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer. 2011; 14(2):101-12. DOI: 10.1007/s10120-011-0041-5. View

18.

Aaronson N, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez N . The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993; 85(5):365-76. DOI: 10.1093/jnci/85.5.365. View

19.

Quan Y, Huang A, Ye M, Xu M, Zhuang B, Zhang P . Comparison of laparoscopic versus open gastrectomy for advanced gastric cancer: an updated meta-analysis. Gastric Cancer. 2015; 19(3):939-50. DOI: 10.1007/s10120-015-0516-x. View

20.

An J, Kim H, Cheong J, Hyung W, Kim C, Noh S . Pathologic and oncologic outcomes in locally advanced gastric cancer with neoadjuvant chemotherapy or chemoradiotherapy. Yonsei Med J. 2013; 54(4):888-94. PMC: 3663211. DOI: 10.3349/ymj.2013.54.4.888. View