Conversion Surgery in Stage IV or Unresectable Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stage IV or Unresectable Gastric Cancer

Intervention / Treatment
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* Procedure: Conversion surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conversion surgery<br>Palliative chemotherapy followed by radical gastrectomy | Procedure: Conversion surgery<br>* Palliative chemotherapy followed by radical gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival | 3-year overall survival after conversion surgery | 3 years after the surgery | 

Secondary Outcome Measures

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