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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440605
• Other study ID #: 2019YJZ55
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• CT
• Gastric Cancer
• Gastric Cancer Stage
• Neoadjuvant Therapy
• Stomach Neoplasms

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