Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-75
SponsorNational Cancer Center, Korea
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient age: < 19 years or age > 75 years
Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years
Previous gastrectomy or esophagectomy history
Multiple gastric cancers
Trial design
Design model
Parallel
Treatments tested in this trial
Endoscopic submucosal dissection
Procedure/SurgeryEndoscopic submucosal dissection by a endoscopist using endoscopic devices
Surgery
Procedure/SurgeryGastrectomy with lymph node dissection by a surgeon
Treatment groups
708 Participants
are divided into 2 treatment groupsGroup A: Endoscopic treatment armActive comparator 1 intervention
Group B: Surgical treatment groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
3-year disease-free survival in the ITT population
Disease-free survival (gastric cancer recurrence or death from any causes)
Time frame
3 years after the last participant enrollmentSecondary outcomes
1
3-year disease-free survival in the PP population
Disease-free survival (gastric cancer recurrence or death from any causes)
Time frame
3 years after the last participant enrollment2
Overall survival
Overall survival (death from any causes)
Time frame
5 years after the last participant enrollment3
Curative resection rate of ESD
Curative resection on the final pathological evaluation
Time frame
2 year after the participant enrollment4
Quality of life changes during follow-up periods
QoL changes using questionnaire
Time frame
3 years after the last participant enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center, Korea
Lead sponsor
Seoul St. Mary's Hospital, The Catholic University
Collaborator
Chilgok Kyungpook National University Hospital
Collaborator
Pusan National University Hospital
Collaborator
Samsung Medical Center
Collaborator
Severance Hospital, Yonsei University College of Medicine
Collaborator
Gangnam Severance Hospital, Yonsei University College of Medicine
Collaborator
Asan Medical Center
Collaborator
Chonnam National University Hospital
Collaborator
Source ClinicalTrials.gov