RecruitingNot ApplicableNCT04890171

Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type

Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type: a Multicenter Randomized Controlled Trial (ERASE-GC Trial)

Sponsor

National Cancer Center, Korea

Enrollment

708 participants

Start Date

Jun 11, 2021

Study Type

INTERVENTIONAL

Conditions

Stomach Cancer Undifferentiated Type Expanded Indication of Endoscopic Resection

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.

Eligibility

Min Age: 19 YearsMax Age: 75 Years

Inclusion Criteria3

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

Exclusion Criteria7

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