S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Nedaplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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