Conversion Surgery in Stage IV or Unresectable Gastric Cancer

Stage IV or Unresectable Gastric Cancer Clinical Trial

— ConGC-II  

Official title:

The Multi-national Multi-institutional Phase 2 Trial for Conversion Surgery in Stage IV or Unresectable Gastric Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03366961
• Other study ID #: ConGC-II
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2019
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to identify the safety and the survival benefit of the conversion surgery in stage IV or unresectable gastric cancer. The study designed single-arm phase II trial. All the patients would undergo curative-intent radical gastrectomy after palliative chemotherapy if the tumor responded to the chemotherapy. Primary endpoint was three-year overall survival. Secondary endpoints included short-term postoperative outcomes within 30 days, three-year relapse free survival, and success rate of conversion surgery (rate of R0 resection).

Description:

The survival rate of patients with stage IV gastric cancer (GC) is very low. Recently, several retrospective studies about conversion surgery have been introduced. The results of the studies showed around 30~40% of three-year survival rate in conversion surgery group. Eight institutions in Catholic University of Korea analyzed 419 stage IV GC patients, and they had divided into four groups: chemotherapy only, chemotherapy followed by gastrectomy, gastrectomy followed by chemotherapy, and best supportive care group. The group of gastrectomy followed by chemotherapy, which is similar with conversion surgery, showed 40% of three-year survival rate. However, the study included only small number of patients who were in conversion surgery group, and had several biases. Thus, we planned multi-national, multi-center phase II trial for conversion surgery in stage IV or unresectable GC.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Gastric adenocarcinoma

• Stage IV or unresectable gastric cancer was diagnosed by pre-operative evaluation including endoscopy, endoscopic ultrasound, Computed tomography (CT), Positron emission tomography-computed tomography (PET CT), or staging laparoscopy

• Partial or complete response to chemotherapy

• Eastern Cooperative Oncology Group (ECOG) score <3

• Who agreed to enroll the study

Exclusion Criteria:

• Synchronous or metachronous malignancy

• remnant gastric cancer

• BMI less than 18.5

• Pregnancy

Related Conditions & MeSH terms

• Stage IV or Unresectable Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Conversion surgery
Palliative chemotherapy followed by radical gastrectomy

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Cho Hyun Park	Peking University, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year overall survival	3-year overall survival after conversion surgery	3 years after the surgery
Secondary	Complication	Short-term complication rate after conversion surgery	30 days after the surgery
Secondary	3-year disease free survival	3-year disease free survival after conversion surgery	3 years after the surgery
Secondary	Success rate of conversion surgery	Rate of R0 resection	30 days after the surgery
Secondary	Response rate of chemotherapy	Response rate of chemotherapy	Operation day