Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type: a Multicenter Randomized Controlled Trial (ERASE-GC Trial)
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
National Cancer Center, Korea
RECRUITING
Goyang-si
Contact Information
Primary
Il Ju Choi, MD, PhD
cij1224@ncc.re.kr
+82-31-920-2282
Backup
Young-Il Kim, MD, PhD
11996@ncc.re.kr
+82-31-920-1712
Time Frame
Start Date: 2021-06-11
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 708
Treatments
Active_comparator: Endoscopic treatment arm
Endoscopic submucosal dissection
Active_comparator: Surgical treatment group
Gastrectomy with lymph node dissection
Related Therapeutic Areas
Sponsors
Collaborators: Asan Medical Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Chonnam National University Hospital, Severance Hospital, Yonsei University College of Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul St. Mary's Hospital, The Catholic University, Chilgok Kyungpook National University Hospital, Pusan National University Hospital
Leads: National Cancer Center, Korea