Actively Recruiting
Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type: a Multicenter Randomized Controlled Trial (ERASE-GC Trial)
Led by National Cancer Center, Korea · Updated on 2024-12-27
708
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center, Korea
Lead Sponsor
S
Seoul St. Mary's Hospital, The Catholic University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical and cost-effectiveness of endoscopic submucosal dissection (ESD) compared to surgery in patients with early gastric cancer (EGC) of the undifferentiated type that meets expanded indications. This multi-center, randomized controlled trial aims to provide high-level evidence due to limitations in previous retrospective studies. ESD is a less invasive treatment preserving the stomach, potentially improving quality of life and reducing medical costs compared to surgery, which remains the standard treatment. Participants are randomly assigned to one of two groups: the endoscopic submucosal dissection group, where an endoscopist performs the procedure using specialized devices, or the surgery group, where a surgeon performs gastrectomy with lymph node dissection. The study focuses on tumors confined to the mucosa without ulcers, 2 cm or smaller, with no lymph node or distant metastasis detected. This trial includes adults aged 19 to 75 and follows them over several years to assess outcomes. During the study, participants undergo evaluations including imaging and endoscopic assessments. Researchers monitor disease-free survival over three years as the primary outcome, along with secondary outcomes such as overall survival, curative resection rates, quality of life changes, treatment complications, and cost-effectiveness. Follow-up and assessments continue for up to five years after enrollment to gather comprehensive data on treatment impact and safety.
CONDITIONS
Brief Title
Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with undifferentiated type early gastric cancer (signet ring cell carcinoma, poorly differentiated tubular adenocarcinoma, or poorly cohesive carcinoma) meeting expanded indication of ESD
- Tumor confined to the mucosa without ulcer and size 2 cm or less on endoscopic evaluation
- No evidence of lymph node metastasis or distant metastasis on abdominal CT scan
- Adult aged 19 to 75 years
- Willing to sign an informed consent form
You will not qualify if you...
- Younger than 19 years or older than 75 years
- Diagnosed and actively treated for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years
- Previous gastrectomy or esophagectomy
- Multiple gastric cancers
- Current treatment for serious medical conditions such as severe heart dysfunction, liver cirrhosis, renal failure, chronic obstructive pulmonary disease or asthma, or uncontrolled infection
- Unable to provide informed consent
- Considered unsuitable for study enrollment by study physicians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure duration plus follow-up
Participants receive endoscopic submucosal dissection, a minimally invasive procedure performed by an endoscopist using endoscopic devices to remove early gastric cancer.
1 baseline visit and multiple follow-up visits over 3 years
Duration - Procedure duration plus follow-up
Participants undergo gastrectomy with lymph node dissection performed by a surgeon as the standard treatment for early gastric cancer.
1 baseline visit and multiple follow-up visits over 3 years
Duration - Up to 3 years after treatment
Participants are monitored for disease-free survival, overall survival, quality of life, treatment-related complications, and cost-effectiveness for up to 3 years after treatment.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769
Actively Recruiting
Research Team
I
Il Ju Choi, MD, PhD
Y
Young-Il Kim, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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