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Conversion Surgery in Stage IV or Unresectable Gastric Cancer (ConGC-II)

C

Cho Hyun Park

Status

Withdrawn

Conditions

Stage IV or Unresectable Gastric Cancer

Treatments

Procedure: Conversion surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03366961
ConGC-II

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Conversion surgery
Other group
Description:
Palliative chemotherapy followed by radical gastrectomy
Treatment:
Procedure: Conversion surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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