Clinical trial NCT03366961: Conversion Surgery in Stage IV or Unresectable Gastric Cancer
Official title: The Multi-national Multi-institutional Phase 2 Trial for Conversion Surgery in Stage IV or Unresectable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stage IV or Unresectable Gastric Cancer
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
name: Peking University
First posted: 2017-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-year overall survival
timeFrame: 3 years after the surgery
Secondary outcomes:
measure: Complication
timeFrame: 30 days after the surgery
measure: 3-year disease free survival
timeFrame: 3 years after the surgery
measure: Success rate of conversion surgery
timeFrame: 30 days after the surgery
measure: Response rate of chemotherapy
timeFrame: Operation day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
References: