NCT04890171Recruiting
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)
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 708 (estimated)
- First submitted
- 11 May 2021
- Start date
- Jun 2021
- Primary completion date
- Feb 2028
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04890171
What you commit to
- Study type: Interventional
- Planned participants: 708
- From Jun 2021 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastrectomy or esophagectomy history
Other illness
- Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years
- 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
- Inadequate conditions for study enrollment according to the evaluation of study physicians
Age
- Patient age: \< 19 years or age \> 75 years
Other
- Inability to provide an informed consent
Who the study is looking for
- 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
Age in the registry: 19 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center - Korea Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.