Comparable Study of Different Radiation Dose in Esophageal Carcinoma

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Radiation therapy plus concurrent chemotherapy is now the standard therapy for patients with localized carcinoma of the esophagus selected for nonsurgical treatment. The standard radiation dose is 50-50.4Gy/1.8-2.0Gy/F.All of this were based on 2D radiation technology. Entering new century, 3D-CRT or IMRT has used on esophageal cancer. In China,the recommend radiation dose of concurrent chemoradiation was 60Gy. The study is a clinical phase III, randomized trial to compare the different radiation dose(60Gy vs 50Gy) of concurrent chemoradiation using 3D-CRT or IMRT in patients with unresectable esophageal carcinoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Histological or cytologic diagnosis of esophageal carcinoma

• ECOG performance status 0-1

• Age:18-70 years

• Joined the study voluntarily and signed informed consent form

• Patients must not have received any prior anticancer therapy

• Unresectable disease, or refuse surgery.Stage Ⅰ-ⅣA（AJCC 2009）

• Target lesions can be measured according to RECIST criteria

• No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN

• Use of an effective contraceptive for adults to prevent pregnancy

• Life expectancy of more than 3 months

Exclusion Criteria:

• Multiple carcinomas of the esophagus,

• Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,

• Metastatic disease (M1),

• A primary tumor that extended to within 2 cm of the gastroesophageal junction,

• Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,

• Concurrent pregnancy or lactation, history of a second malignancy other than nonmelanoma skin cancer