Surgery or Chemoradiation for Esophageal Cancer
Phase 3
Completed
- Conditions
- Esophageal Cancers
- Interventions
- Procedure: EsophagectomyRadiation: Definitive chemoradiation
- Registration Number
- NCT01032967
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Eligible patients had mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable.
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Exclusion Criteria
- The investigators excluded those patients who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
- Those patients who were older than 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy were also excluded.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery, esophagectomy Esophagectomy The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy Definitive chemoradiation Definitive chemoradiation 3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.
- Primary Outcome Measures
Name Time Method Overall survival and disease-free survival 2 year and 5 year
- Secondary Outcome Measures
Name Time Method Quality of life and function outcomes 2 year