Clinical trial NCT04440605: A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis
Official title: A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis: A Prospective, Multicenter, Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Gastric Cancer Stage
CT
Neoadjuvant Therapy
Keywords: Gastric cancer
Clinical TNM staging
Adenocarcinoma
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Ruijin Hospital
name: West China Hospital
name: Beijing 302 Hospital
name: Fudan University
name: Peking University International Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Fujian Medical University Union Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Chinese PLA General Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Tianjin Medical University General Hospital
name: The Second Affiliated Hospital of Dalian Medical University
name: Wuhan Union Hospital, China
name: Peking University People's Hospital
name: Weifang People's Hospital
name: Second Hospital of Jilin University
name: Fujian Province Tumor Hospital
name: Shanxi Province Cancer Hospital
name: The First Affiliated Hospital of Nanchang University
name: Tianjin Medical University Cancer Institute and Hospital
name: Shanghai Zhongshan Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: The Affiliated Hospital of Qingdao University
name: The First Affiliated Hospital of Xiamen University
name: Beijing Hospital
name: Beijing Friendship Hospital
name: Qingdao Municipal Hospital
name: Guangdong Provincial People's Hospital
name: Affiliated Hospital of Qinghai University
name: Shandong Provincial Hospital
name: The First Hospital of Jilin University
name: Nanfang Hospital, Southern Medical University
name: Zhongshan Hospital Xiamen University
name: Hebei Medical University Fourth Hospital
First posted: 2020-06-19
Enrollment: 968
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy of cIII
timeFrame: 1.5 years
Secondary outcomes:
measure: Diagnostic Accuracy of cTxNy
timeFrame: 1.5 years
measure: Diagnostic Accuracy of cN+
timeFrame: 1.5 years
measure: Diagnostic Accuracy of cT3/4
timeFrame: 1.5 years
measure: Diagnostic Accuracy of cTN
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
city: Beijing
country: China
facility: 301 Hospital
state: Beijing
city: Beijing
country: China
facility: 302 Military Hospital of China
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Peoples Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Tumor Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Heilongjiang Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Chang chun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Affiliated Hospital-Dalian Medical University
state: Liaoning
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Cancer center
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Tumour Hospital
state: Shanxi
city: Chendu
country: China
facility: West China Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Ürümqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References:
citation: 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.