NCT04890171

Brief Summary

This multi-center, randomized controlled trial is designed to evaluate clinical effectiveness and cost-effectiveness of ESD for undifferentiated type of EGC meeting the expanded indication compared with surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
708

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress64%
Jun 2021Feb 2029

First Submitted

Initial submission to the registry

May 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

June 11, 2021

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

6.7 years

First QC Date

May 11, 2021

Last Update Submit

December 25, 2024

Conditions

Stomach CancerUndifferentiated TypeExpanded Indication of Endoscopic Resection

Keywords

Early gastric cancerEndoscopic submucosal dissectionSurgeryUndifferentiated typeExpanded indication

Outcome Measures

Primary Outcomes (1)

  • 3-year disease-free survival in the ITT population

    Disease-free survival (gastric cancer recurrence or death from any causes)

    3 years after the last participant enrollment

Secondary Outcomes (6)

  • 3-year disease-free survival in the PP population

    3 years after the last participant enrollment

  • Overall survival

    5 years after the last participant enrollment

  • Curative resection rate of ESD

    2 year after the participant enrollment

  • Quality of life changes during follow-up periods

    3 years after the last participant enrollment

  • Treatment related complications (adverse events)

    3 years after the last participant enrollment

  • +1 more secondary outcomes

Study Arms (2)

Endoscopic treatment arm

ACTIVE COMPARATOR

Endoscopic submucosal dissection

Procedure: Endoscopic submucosal dissection

Surgical treatment group

ACTIVE COMPARATOR

Gastrectomy with lymph node dissection

Procedure: Surgery

Interventions

Endoscopic submucosal dissectionPROCEDURE

Endoscopic submucosal dissection by a endoscopist using endoscopic devices

Endoscopic treatment arm
SurgeryPROCEDURE

Gastrectomy with lymph node dissection by a surgeon

Surgical treatment group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are diagnosed with undifferentiated type EGC (signet ring cell carcinoma, poorly differentiated tubular adenocarcinoma, or poorly cohesive carcinoma) that meets the expanded indication of ESD 1) Tumor confined to the mucosa without ulcer, and size ≤2 cm on endoscopic evaluations 2) No evidence of lymph node metastasis and distant metastasis on abdominal CT scan
  • Adult patients aged 19-75 years
  • Patients who had willingness to sign an informed consent form

You may not qualify if:

  • Patient age: \< 19 years or age \> 75 years
  • Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years
  • Previous gastrectomy or esophagectomy history
  • Multiple gastric cancers
  • Current treatment for serious medical condition which could hinder study participation including severe heart dysfunction, liver cirrhosis, renal failure, chronic obstructive pulmonary disease or asthma, or uncontrolled infection
  • Inability to provide an informed consent
  • Inadequate conditions for study enrollment according to the evaluation of study physicians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal ResectionSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresMinimally Invasive Surgical Procedures

Study Officials

  • Il Ju Choi, MD, PhD

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Il Ju Choi, MD, PhD

CONTACT

+82-31-920-2282cij1224@ncc.re.kr

Young-Il Kim, MD, PhD

CONTACT

+82-31-920-171211996@ncc.re.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Scientist

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 18, 2021

Study Start

June 11, 2021

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2029

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

KR(1)