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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04440605
Other study ID # 2019YJZ55
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date October 2022

Study information

Verified date June 2020
Source Peking University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 968
Est. completion date October 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Preoperative staging——D2 gastrectomy——Postoperative staging
Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy

Locations

Country Name City State
China 301 Hospital Beijing Beijing
China 302 Military Hospital of China Beijing Beijing
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing
China Beijing Hospital Beijing Beijing
China Peking University Cancer Hospital & Institute Beijing Beijing
China Peking University International Hospital Beijing Beijing
China Peking University Peoples Hospital Beijing Beijing
China The First Hospital of Jilin University Chang chun Jilin
China The Second Hospital of Jilin University Chang chun Jilin
China West China Hospital Chendu Sichuan
China The Second Affiliated Hospital-Dalian Medical University Dalian Liaoning
China Fujian Medical University Union Hospital Fuzhou Fujian
China Fujian Tumor Hospital Fuzhou Fujian
China Guangdong General Hospital Guangzhou Guangdong
China Guangdong Hospital of Traditional Chinese Medicine Guangzhou Guangdong
China Nanfang Hospital of Southern Medical University Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
China Heilongjiang Cancer Hospital Harbin Heilongjiang
China Shandong Provincial Hospital Jinan Shandong
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Jiangsu People's Hospital Nanjing Jiangsu
China Qingdao Municipal Hospital Qingdao Shandong
China The Affiliated Hospital of Qingdao University Qingdao Shandong
China Fudan University Cancer center Shanghai Shanghai
China Ruijin Hospital Shanghai Shanghai
China Shanghai Renji Hospital Shanghai Shanghai
China Zhongshan Hospital Shanghai Shanghai
China Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
China Shanxi Tumour Hospital Taiyuan Shanxi
China Tianjin Medical University Cancer Hospital Tianjin Tianjin
China Tianjin Medical University General Hospital Tianjin Tianjin
China First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
China Weifang People's Hospital Weifang Shandong
China Wuhan Union Hospital Wuhan Hubei
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
China The First Affiliated Hospital of Xiamen University Xiamen Fujian
China Zhongshan Hospital of Xiamen University Xiamen Fujian
China Qinghai University Affiliated Hospital Xining Qinghai

Sponsors (36)

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

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic Accuracy of cIII Proportion of pathological stage I among clinical stage III(T3-4aNx) diagnosis patients 1.5 years
Secondary Diagnostic Accuracy of cTxNy Proportion of pathological stage I among clinical TxNy(x+y>4) stage diagnosis patients 1.5 years
Secondary Diagnostic Accuracy of cN+ Proportion of pathological stage I among clinical N1-3 stage diagnosis patients 1.5 years
Secondary Diagnostic Accuracy of cT3/4 Proportion of pathological stage I among clinical T3-4 stage diagnosis patients 1.5 years
Secondary Diagnostic Accuracy of cTN The concordance rate for clinical staging 1.5 years
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