Conversion Surgery in Stage IV or Unresectable Gastric Cancer

Not Applicable

Withdrawn

• Conditions: Stage IV or Unresectable Gastric Cancer
• Interventions: Procedure: Conversion surgery

• Registration Number: NCT03366961
• Lead Sponsor: Cho Hyun Park

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Primary Completion: 2019-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conversion surgery	Conversion surgery	Palliative chemotherapy followed by radical gastrectomy

Primary Outcome Measures

Name	Time	Method
3-year overall survival	3 years after the surgery	3-year overall survival after conversion surgery

Secondary Outcome Measures

Name	Time	Method
Complication	30 days after the surgery	Short-term complication rate after conversion surgery
Response rate of chemotherapy	Operation day	Response rate of chemotherapy
3-year disease free survival	3 years after the surgery	3-year disease free survival after conversion surgery
Success rate of conversion surgery	30 days after the surgery	Rate of R0 resection

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of