Radiation Dose Study of Concurrent Chemoradiotherapy With Cisplatin Plus Fluorouracil in Oesophageal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine the optimal radiation dosage used in concurrent chemo-radiotherapy in Chinese population. A dose climbing experiment is carried out with an initiate dose of 50Gy conventionally applied in Western countries.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simcere Pharmaceutical Co., Ltd
• Treatments: Cisplatin; Fluorouracil

Criteria

Inclusion Criteria:

1. Biopsy-proven squamous cell carcinoma or adenocarcinoma of thoracic or cervical esophagus or gastroesophageal junction esophagus, including the gastroesophageal junction

2. Measurable lesion

3. Age > 18 years

4. Karnofsky performance score > 70

5. Life expectancy > 3 months

6. Adequate bone marrow function (white blood cell [WBC] count ≥ 3.5 109/L, neutrophil count ≥ 2.0 109/L, and platelet count ≥ 100 109/L), adequate renal function (creatinine ≤ 2 mg/dL or creatinine clearance ≥ 50 mL/min), and normal liver function (aspartate aminotransferase and alanine aminotransferase less than two times the upper limit of normal, total serum bilirubin ≤ 1.5 mg/dL).

Exclusion Criteria:

1. Prior systemic chemotherapy for EC

2. Evidence of distant metastatic disease

3. Evidence of uncontrolled medical conditions (e.g.,serious infection,grade 4 hypertension,congestive heart failure)

4. A history of concomitant or previous malignancy.

5. Physical evidence of peripheral neuropathy or hearing loss