Comparing endoscopic resection and surgery for early gastric cancer

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

This study is testing if a less invasive procedure called endoscopic submucosal dissection can be as effective and cost-friendly as traditional surgery for people with early gastric cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 708 (estimated)
• Ages: 19 Years to 75 Years
• Sex: All
• Sponsor: National Cancer Center, Korea (other gov)
• Locations: 1 site (Goyang-si, Gyeonggi-do)
• Trial ID: NCT04890171 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized controlled trial evaluates the clinical effectiveness and cost-effectiveness of endoscopic submucosal dissection (ESD) for undifferentiated type early gastric cancer (EGC) compared to traditional surgery. ESD is a minimally invasive procedure that preserves the stomach and may offer a better quality of life and lower medical costs for patients. The study focuses on patients with tumors confined to the mucosa, measuring ≤2 cm, and aims to provide evidence on the long-term outcomes of ESD versus surgery. Previous studies have suggested favorable outcomes for ESD, making this trial crucial for validating its expanded indication.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19-75 diagnosed with undifferentiated type early gastric cancer that meets specific criteria for endoscopic submucosal dissection.

Not a fit: Patients with multiple gastric cancers, previous gastrectomy, or serious medical conditions that could hinder participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for early gastric cancer, improving patient quality of life and reducing healthcare costs.

How similar studies have performed: Previous studies have shown favorable outcomes for endoscopic submucosal dissection in similar patient populations, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. 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
2. Adult patients aged 19-75 years
3. Patients who had willingness to sign an informed consent form

Exclusion Criteria:

1. Patient age: \< 19 years or age \> 75 years
2. Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years
3. Previous gastrectomy or esophagectomy history
4. Multiple gastric cancers
5. 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
6. Inability to provide an informed consent
7. Inadequate conditions for study enrollment according to the evaluation of study physicians

Where this trial is running

Goyang-si, Gyeonggi-do

• National Cancer Center, Korea — Goyang-si, Gyeonggi-do, South Korea (RECRUITING)

Study contacts

• Principal investigator: Il Ju Choi, MD, PhD — National Cancer Center, Korea
• Study coordinator: Il Ju Choi, MD, PhD

Conditions: Stomach Cancer, Undifferentiated Type, Expanded Indication of Endoscopic Resection, Early gastric cancer, Endoscopic submucosal dissection, Surgery, Undifferentiated type, Expanded indication