Comparison of endoscopic resection and surgery for early gastric cancer with undifferentiated histological type
- Conditions
- Neoplasms
- Registration Number
- KCT0006159
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 708
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year disease-free survival in the ITT population
- Secondary Outcome Measures
Name Time Method 3-year disease-free survival in the PP population ;Overall survival;Curative resection rate of ESD;Quality of life changes during follow-up periods;Treatment related complications (adverse events);Cost-effectiveness of treatments