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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

968

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach

1 country

38 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

June 17, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed

12 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed

Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

1.8 years

First QC Date

June 17, 2020

Last Update Submit

June 17, 2020

Conditions

Gastric Cancer Gastric Cancer Stage CT Neoadjuvant Therapy

Keywords

Gastric cancerClinical TNM stagingAdenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Diagnostic Accuracy of cTxNy
1.5 years
Diagnostic Accuracy of cN+
1.5 years
Diagnostic Accuracy of cT3/4
1.5 years
Diagnostic Accuracy of cTN
1.5 years

Study Arms (3)

cI

clincal TNM stage I

Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging

cII

clinical TNM stage II

Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging

cIII

clinical TNM stage III

Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging

Interventions

Preoperative staging--D2 gastrectomy--Postoperative stagingPROCEDURE

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

cIcIIcIII

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Sites (38)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

301 Hospital