NCT03366961

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

December 4, 2017

Last Update Submit

September 17, 2019

Conditions

Stage IV or Unresectable Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 3-year overall survival

    3-year overall survival after conversion surgery

    3 years after the surgery

Secondary Outcomes (4)

  • Complication

    30 days after the surgery

  • 3-year disease free survival

    3 years after the surgery

  • Success rate of conversion surgery

    30 days after the surgery

  • Response rate of chemotherapy

    Operation day

Study Arms (1)

Conversion surgery

OTHER

Palliative chemotherapy followed by radical gastrectomy

Procedure: Conversion surgery

Interventions

Conversion surgeryPROCEDURE

Palliative chemotherapy followed by radical gastrectomy

Conversion surgery

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Synchronous or metachronous malignancy
  • remnant gastric cancer
  • BMI less than 18.5
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 06523, South Korea

Location

MeSH Terms

Interventions

Conversion to Open Surgery

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 8, 2017

Study Start

December 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2022

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

KR(1)