Stage IV or Unresectable Gastric Cancer
Conditions
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.
Interventions
PROCEDUREConversion surgery
Palliative chemotherapy followed by radical gastrectomy
Sponsors
The Catholic University of Korea
Peking University
Cho Hyun Park
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival | 3 years after the surgery | 3-year overall survival after conversion surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication | 30 days after the surgery | Short-term complication rate after conversion surgery |
| 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 |
| Response rate of chemotherapy | Operation day | Response rate of chemotherapy |
Countries
South Korea
Outcome results
None listed