Status:
COMPLETED
S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.
Detailed Description
Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal Cancer. Methods: ...
Eligibility Criteria
Inclusion
- Histologic proof of primary squamous cell or adenocarcinoma of the esophagus
- Locoregionally advanced carcinoma of esophagus without systemic metastases
- Zubrod Performance Status 0-1;
- Patients ≥ 18 years of age;
- No hypersensitivity to E. coli -derived products;
- AGC ≥ 1500/mm3, platelets ≥ 150,000/mm3, Hgb ≥ 10 gm%, serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 65 cc/min; serum calcium ≤ 11gm/dl;
- Patients with prior malignancy are eligible if curable non-melanoma skin cancer or cervical cancer in situ or disease free ≥ 5 years;
- No prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within the past 5 years; no prior esophageal or gastric surgery;
- Written informed consent.
Exclusion
- Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Prior systemic chemotherapy or radiation therapy for esophageal cancer
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01175460
Start Date
January 1 2010
End Date
January 1 2011
Last Update
March 6 2012
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022