Last updated on July 2020

Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Esophageal Disorders | Esophageal Diseases | head and neck cancer | Esophageal Cancer
  • Age: Between 19 - 79 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age 19 years and < 80 years
  2. Histologically confirmed squamous cell carcinoma of the esophagus
  3. Clinical stage as cT1N0M0 (AJCC/UICC 7th Edition) according to upper GI endoscopy or endoscopic ultrasound and chest computed tomography (CT) scans
  4. Pathologic examination after endoscopic submucosal dissection confirmed the presence of submucosal invasion (pathologic T1b) or lymphovascular invasion
  5. 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
  6. Participants has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) 1000/L, hemoglobin 8 g/dL, and platelets 85,000/L
  7. 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
  8. Participants should agree to participate in the study and sign the informed consent form

Exclusion Criteria:

  1. Cervical esophageal cancer (proximal to 20cm from incisor teeth)
  2. 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))
  3. Recurrent esophageal cancer
  4. 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
  5. Gastric conduit is not available for esophageal reconstruction (ex.: previous history of gastrectomy)
  6. Synchronous or metachronous multiple cancers (within the past 3 years) with the exclusion of skin cancer, well differentiated thyroid cancer, early gastric cancer achieving curative endoscopic resection, or low grade prostate cancer (Gleason Score6)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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