A phase III randomized comparison of surgery alone vs. surgery followed by adjuvant chemotherapy for patients with curatively resected esophageal cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0003636
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 338
1) Patients must have histologically or cytologically documented esophageal cancer (squamous cell carcinoma) including esoophgeal squamous cell cancer of the esophagogastric junction
2) Patients who underwent curative surgical resection for esophageal ca (postop. 3-8 wks)
3) T 2-3 or N1
4) Age: 18-70
5) ECOG performance status: 0-2
6) No previous history of chemotherapy or radiation therapy
7) Adequate bone marrow, liver, kidney function
8) Signed written informed consent
1) Cervical esophageal cancer
2) Subject who received neoadjuvant chemotherapy, biologic therapy or radiation therapy
3) Evidence of brain metastasis
4) Concurrent serious medical or major psychiatric illness
5) Active or uncontrolled infection
6) Pregnant or lactating woman
7) Gastroesophageal junction involvement of stomach cancer
8) Synchronous or metachronous double primary cancer
9) History of other malignancy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease free survival
- Secondary Outcome Measures
Name Time Method overall survival;pattern of failure;toxicity profile;predictive markers