A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis

A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis: A Prospective, Multicenter, Cohort Study

With the introducing of neoadjuvant therapy, it becomes ever more important to evaluate the preoperative TNM (cTNM) stage accurately facilitating preoperative treatment as well as the adjuvant therapy.

At present, the recommendation of neoadjuvant chemotherapy varies among guidelines especially between eastern and western countries. According to the updated Japanese gastric cancer treatment guidelines (ver.5), neoadjuvant chemotherapy is the recommended standard procedure for patients with cT2-4 stages. However, the acknowledgement of preoperative therapy accompanied by the higher risk of overtreatment. As mentioned in JCOG1302-A, the overall precision rate in cT staging is 38.8%. Patients diagnosed with pI stages postoperatively account for 6.5% in cT3-4N+ treatment indicating more likely to avoiding the overtreatment comparing to patients with other cT stages.

Inspired by JCOG1302-A, this multicentre study prospectively collect data in preoperative TNM staging assessment using CT(computed tomography, CT) scan and the postoperative TNM (pTNM) staging according to histopathologically examination. By analyzing the accordance between the cTNM and pTNM, this study aims to evaluate the current accuracy of the cTNM staging in china, verifying the proportion of pI stages less than 5% in cIII stage diagnosis patients, learning the overtreating rate in neoadjuvant chemotherapy in China and furthermore, to discover the scope of beneficiaries for neoadjuvant chemotherapy.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer; Neoadjuvant Therapy; Gastric Cancer Stage; CT
• Intervention / Treatment: Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging

Detailed Description

OBJECTIVES:

I. Confirm the inclusion of pathological stage I (pI) among clinical stage III(T3-4aNx) (cIII) diagnosis patients less than 5% II. Figure out the suitable criterion of NAC and avoid overtreatment, by examining the rate of pI rate in different diagnostic criterion groups, including cIII, TxNy(x+y>4), cN1-3, cT3-4.

III. Evaluate the current state of diagnostic accuracy of preoperative CT staging in china.

OUTLINE:

This is a prospective, multi-centers, cohort study of clinical TNM staging diagnostic accuracy.

Patients are divided into 3 preoperative stage groups according to AJCC 8th edition (cI, cII, cIII) preoperatively. All patients receive the D2 gastrectomy after cTNM diagnosis and the pathological stages is given following surgery.

The concordance of preoperative staging is evaluated in each cohorts as well as the subgroups to obtain the accuracy rate. The pI proportion will calculate in each latent criterion groups to assess the suitable NAC criteria.

PROJECTED ACCRUAL: A total of 968 patients will be accrued for this study within two years.

• Study Type: Observational
• Enrollment (Anticipated): 968

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital & Institute
      • Contact: Ziyu Li, M.D.; Phone Number: 86-010-8819-6606; Email: ziyu_li@hsc.pku.edu.cn
      • Contact: Ziyu Li, M.D., Ph.D; Phone Number: 86-010-8819-6605; Email: ziyu_li@hsc.pku.edu.cn
      • Sub-Investigator: Xiangji Ying, M.P.H
      • Sub-Investigator: Chao Gao, M.D.
    • Beijing, Beijing, China
      • Not yet recruiting
      • 301 Hospital
      • Contact: Xiaohui Du, M.D.
    • Beijing, Beijing, China
      • Not yet recruiting
      • 302 Military Hospital of China
      • Contact: Feng Liang, M.D.
    • Beijing, Beijing, China
      • Not yet recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Jun Zhang, M.D.
    • Beijing, Beijing, China
      • Not yet recruiting
      • Beijing Hospital
      • Contact: Gang Zhao, M.D.
    • Beijing, Beijing, China
      • Not yet recruiting
      • Peking University International Hospital
      • Contact: Ning Ning, M.D.
    • Beijing, Beijing, China
      • Not yet recruiting
      • Peking University Peoples Hospital
      • Contact: Bin Liang, M.D.
  • Fujian
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • Fujian Medical University Union Hospital
      • Contact: Zhaohui Zheng, M.D.
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • Fujian Tumor Hospital
      • Contact: Weidong Zang, M.D.
    • Xiamen, Fujian, China
      • Not yet recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Jun You, M.D.
    • Xiamen, Fujian, China
      • Not yet recruiting
      • Zhongshan Hospital of Xiamen University
      • Contact: Xingfeng Qiu, M.D.
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong General Hospital
      • Contact: Yong Li, M.D.
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • The First Affiliated Hospital, Sun Yat-sen University
      • Contact: Wu Song, M.D.
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong Hospital of Traditional Chinese Medicine
      • Contact: Wei Wang, M.D.
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Nanfang Hospital of Southern Medical University
      • Contact: Jiang Yu, M.D.
  • Hebei
    • Shijiazhuang, Hebei, China
      • Not yet recruiting
      • Fourth Hospital of Hebei Medical University
      • Contact: Qun Zhao, M.D.
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Not yet recruiting
      • Heilongjiang Cancer Hospital
      • Contact: Kuan Wang, M.D.
  • Hubei
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Wuhan Union Hospital
      • Contact: Kaixiong Tao, M.D.
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • Jiangsu People's Hospital
      • Contact: Zekuan Xu, M.D.
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • The first affiliated Hospital of Nanchang University
      • Contact: Zhengrong Li, M.D.
  • Jilin
    • Chang chun, Jilin, China
      • Not yet recruiting
      • The First Hospital of Jilin University
      • Contact: Daguang Wang, M.D.
    • Chang chun, Jilin, China
      • Not yet recruiting
      • The Second Hospital of Jilin University
      • Contact: Jiaming Zhu, M.D.
  • Liaoning
    • Dalian, Liaoning, China
      • Not yet recruiting
      • The Second Affiliated Hospital-Dalian Medical University
      • Contact: Xinsheng Zhang, M.D.
  • Qinghai
    • Xining, Qinghai, China
      • Not yet recruiting
      • Qinghai University Affiliated Hospital
      • Contact: Su Yan, M.D.
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Not yet recruiting
      • First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Lin Fan, M.D.
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Shandong Provincial Hospital
      • Contact: Changqing Jing, M.D.
    • Qingdao, Shandong, China
      • Not yet recruiting
      • QingDao Municipal Hospital
      • Contact: Hong Qi, M.D.
    • Qingdao, Shandong, China
      • Not yet recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Zhaojian Niu, M.D.
    • Weifang, Shandong, China
      • Not yet recruiting
      • WeiFang People's Hospital
      • Contact: Jianjun Qu, M.D.
  • Shanghai
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Fudan University Cancer Center
      • Contact: Hua Huang, M.D.
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Ruijin Hospital
      • Contact: Lu Zang, M.D.
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Shanghai Renji Hospital
      • Contact: Gang Zhao, M.D.
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Zhongshan hospital
      • Contact: Fenglin Liu, M.D.
  • Shanxi
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • Shanxi Tumour Hospital
      • Contact: Qingxing Huang, M.D.
  • Sichuan
    • Chendu, Sichuan, China
      • Not yet recruiting
      • West China Hospital
      • Contact: Kun Yang, M.D.
  • Tianjin
    • Tianjin, Tianjin, China
      • Not yet recruiting
      • Tianjin Medical University Cancer Hospital
      • Contact: Jingyu Deng, M.D.
    • Tianjin, Tianjin, China
      • Not yet recruiting
      • Tianjin Medical University General Hospital
      • Contact: Weihua Fu, M.D.
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Not yet recruiting
      • First Affiliated Hospital of Xinjiang Medical University
      • Contact: Wenbin Zhang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with endoscopically biopsy-proven adenocarcinoma of the stomach and with contrast-enhanced CT cI-III diagnosis prior to surgery will receive treatment.

Description

Inclusion Criteria:

• Histological prove of adenocarcinoma of the stomach by endoscopy
• Preoperative imaging data by contrast-enhanced CT and clinical TNM stages were given
• No evidence of stage IV disease
• No previous gastrectomy or preoperative treatment.

Exclusion Criteria:

• Discovery of distant metastasis (stage IV) during surgery
• Number of retrieved lymph node less than 15

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cI; clincal TNM stage I	Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging; Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy
cII; clinical TNM stage II	Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging; Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy
cIII; clinical TNM stage III	Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging; Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of cIII	Proportion of pathological stage I among clinical stage III(T3-4aNx) diagnosis patients	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of cTxNy	Proportion of pathological stage I among clinical TxNy(x+y>4) stage diagnosis patients	1.5 years
Diagnostic Accuracy of cN+	Proportion of pathological stage I among clinical N1-3 stage diagnosis patients	1.5 years
Diagnostic Accuracy of cT3/4	Proportion of pathological stage I among clinical T3-4 stage diagnosis patients	1.5 years
Diagnostic Accuracy of cTN	The concordance rate for clinical staging	1.5 years

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Shanxi Province Cancer Hospital; The First Affiliated Hospital of Nanchang University; Zhongshan Hospital Xiamen University; Guangdong Provincial Hospital of Traditional Chinese Medicine; Peking University People's Hospital; Fudan University; Beijing Friendship Hospital; Shanghai Zhongshan Hospital; Beijing 302 Hospital; Chinese PLA General Hospital; First Affiliated Hospital, Sun Yat-Sen University; RenJi Hospital; West China Hospital; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Hospital of Qingdao University; Nanfang Hospital of Southern Medical University; Peking University International Hospital; Ruijin Hospital; Shandong Provincial Hospital; Tianjin Medical University Cancer Institute and Hospital; Beijing Hospital; Guangdong Provincial People's Hospital; Qingdao Municipal Hospital; The First Hospital of Jilin University; Wuhan Union Hospital, China; Tianjin Medical University General Hospital; Fujian Medical University Union Hospital; Hebei Medical University Fourth Hospital; First Affiliated Hospital of Xinjiang Medical University; Second Hospital of Jilin University; The Second Affiliated Hospital of Dalian Medical University; Affiliated Hospital of Qinghai University; The First Affiliated Hospital of Xiamen University; Weifang People's Hospital; Fujian Province Tumor Hospital

Publications and helpful links

General Publications

• Fukagawa T, Katai H, Mizusawa J, Nakamura K, Sano T, Terashima M, Ito S, Yoshikawa T, Fukushima N, Kawachi Y, Kinoshita T, Kimura Y, Yabusaki H, Nishida Y, Iwasaki Y, Lee SW, Yasuda T, Sasako M; Stomach Cancer Study Group of the Japan Clinical Oncology Group. A prospective multi-institutional validity study to evaluate the accuracy of clinical diagnosis of pathological stage III gastric cancer (JCOG1302A). Gastric Cancer. 2018 Jan;21(1):68-73. doi: 10.1007/s10120-017-0701-1. Epub 2017 Feb 13.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Gastric cancer; Adenocarcinoma; Clinical TNM staging
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2019YJZ55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No