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

Sponsor

Peking University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04440605

Collaborator

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

968

Enrollment

Locations

Anticipated Duration (Months)

25.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Gastric Cancer Stage CT Neoadjuvant Therapy	Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging

Detailed Description

OBJECTIVES:

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.
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 Design

Study Type:

Observational

Anticipated Enrollment :

968 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Diagnostic Accuracy of cIII [1.5 years]
Proportion of pathological stage I among clinical stage III(T3-4aNx) diagnosis patients

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital & Institute	Beijing	Beijing	China	100142
2	301 Hospital	Beijing	Beijing	China
3	302 Military Hospital of China	Beijing	Beijing	China
4	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China
5	Beijing Hospital	Beijing	Beijing	China
6	Peking University International Hospital	Beijing	Beijing	China
7	Peking University Peoples Hospital	Beijing	Beijing	China
8	Fujian Medical University Union Hospital	Fuzhou	Fujian	China
9	Fujian Tumor Hospital	Fuzhou	Fujian	China
10	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China
11	Zhongshan Hospital of Xiamen University	Xiamen	Fujian	China
12	Guangdong General Hospital	Guangzhou	Guangdong	China
13	Guangdong Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong	China
14	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong	China
15	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
16	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
17	Heilongjiang Cancer Hospital	Harbin	Heilongjiang	China
18	Wuhan Union Hospital	Wuhan	Hubei	China
19	Jiangsu People's Hospital	Nanjing	Jiangsu	China
20	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China
21	The First Hospital of Jilin University	Chang chun	Jilin	China
22	The Second Hospital of Jilin University	Chang chun	Jilin	China
23	The Second Affiliated Hospital-Dalian Medical University	Dalian	Liaoning	China
24	Qinghai University Affiliated Hospital	Xining	Qinghai	China
25	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China
26	Shandong Provincial Hospital	Jinan	Shandong	China
27	Qingdao Municipal Hospital	Qingdao	Shandong	China
28	The Affiliated Hospital of Qingdao University	Qingdao	Shandong	China
29	Weifang People's Hospital	Weifang	Shandong	China
30	Fudan University Cancer center	Shanghai	Shanghai	China
31	Ruijin Hospital	Shanghai	Shanghai	China
32	Shanghai Renji Hospital	Shanghai	Shanghai	China
33	Zhongshan Hospital	Shanghai	Shanghai	China
34	Shanxi Tumour Hospital	Taiyuan	Shanxi	China
35	West China Hospital	Chendu	Sichuan	China
36	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin	China
37	Tianjin Medical University General Hospital	Tianjin	Tianjin	China
38	First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang	China