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

Sponsor
Cho Hyun Park (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03366961
Collaborator
The Catholic University of Korea (Other), Peking University (Other)
0
Enrollment
1
Location
1
Arm
61
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Conversion surgery
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Multi-national Multi-institutional Phase 2 Trial for Conversion Surgery in Stage IV or Unresectable Gastric Cancer
Actual Study Start Date :
Dec 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Conversion surgery

Palliative chemotherapy followed by radical gastrectomy

Procedure: Conversion surgery
Palliative chemotherapy followed by radical gastrectomy

Outcome Measures

Primary Outcome Measures

  1. 3-year overall survival [3 years after the surgery]

    3-year overall survival after conversion surgery

Secondary Outcome Measures

  1. Complication [30 days after the surgery]

    Short-term complication rate after conversion surgery

  2. 3-year disease free survival [3 years after the surgery]

    3-year disease free survival after conversion surgery

  3. Success rate of conversion surgery [30 days after the surgery]

    Rate of R0 resection

  4. Response rate of chemotherapy [Operation day]

    Response rate of chemotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul St. Mary's Hospital Seoul Korea, Republic of 06523

Sponsors and Collaborators

  • Cho Hyun Park
  • The Catholic University of Korea
  • Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cho Hyun Park, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT03366961
Other Study ID Numbers:
  • ConGC-II
First Posted:
Dec 8, 2017
Last Update Posted:
Sep 19, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Sep 19, 2019