Status:
ACTIVE_NOT_RECRUITING
Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Ministry of Health & Welfare, Korea
Conditions:
Esophageal Cancer
Eligibility:
All Genders
19-79 years
Phase:
NA
Brief Summary
This is a randomized noninferiority multicenter trial. Patients will be stratified according to the participating hospital. Patients will be randomized to one of the treatment arms. Arm A: Patients w...
Detailed Description
* Compare 1-year, 2-year, 3-year, 5-year, 6-year, 7-year, 8-year, 9-year, 10-year overall survival between concurrent chemoradiotherapy and esophagectomy among patients who require additional treatmen...
Eligibility Criteria
Inclusion
- Age ≥ 19 years and \< 80 years
- Histologically confirmed squamous cell carcinoma of the esophagus
- Clinical stage as cT1N0M0 (AJCC/UICC 7th Edition) according to upper GI endoscopy or endoscopic ultrasound and chest computed tomography (CT) scans
- Pathologic examination after endoscopic submucosal dissection confirmed the presence of submucosal invasion (pathologic T1b) or lymphovascular invasion
- For participants with multiple lesions, all of them should be resected with endoscopic submucosal dissection and at least one lesion should have pathologic submucosal invasion (pT1b) or lymphovascular invasion
- Participants has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1000/µL, hemoglobin ≥8 g/dL, and platelets ≥85,000/µL
- Participants has adequate hepatic and renal function as defined by aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal ; a total bilirubin ≤1.5 times the upper limit of normal ; creatinine clearance ≥ 30mL/min/1.73m2
- Participants should agree to participate in the study and sign the informed consent form
Exclusion
- Cervical esophageal cancer (proximal to 20cm from incisor teeth)
- Regional lymph node metastasis (cN+) or distant metastasis (cM1) are suspected or confirmed on chest CT scans or positron emission tomography (PET)/CT scans (Equivocal results will be regarded as no metastasis. However, it can also perform a biopsy if necessary (optional))
- Recurrent esophageal cancer
- Uncontrolled systemic disease which makes participants medically unfit for additional treatment (esophagectomy or concurrent chemoradiotherapy) such as congestive heart failure, interstitial lung disease, severe pulmonary emphysema or chronic renal failure
- Gastric conduit is not available for esophageal reconstruction (ex.: previous history of gastrectomy)
- Synchronous or metachronous multiple cancers (within the past 3 years) with the exclusion of skin cancer, well differentiated thyroid cancer, carcinoma in situ, early cancer achieving curative endoscopic resection, or low grade prostate cancer (Gleason Score≤6)
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03306901
Start Date
October 20 2017
End Date
December 31 2033
Last Update
May 23 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Center
Goyang-si, South Korea
2
Pusan National University Hospital
Pusan, South Korea, 06351
3
Seoul National University Bundang Hospital
Seongnam, South Korea
4
Asan Medical Center
Seoul, South Korea