Comparable Study of Different Radiation Dose in Esophageal Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomised Phase 3 Study of High-dose Versus Standard-dose Radiation of Inoperable Esophageal Carcinoma Treated With Concurrent Chemoradiation

Conditions
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Esophageal Carcinoma

Intervention / Treatment
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* Radiation: intensity modulated radiation therapy in both arms
* Drug: concurrent chemotherapy with radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-dose<br>concurrent chemoradiation:CT:DDP 25mg/m2 D1+docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：60Gy/30F/6W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 75mg/m2 D1+docetaxel 75mg/m2 D1, Q3W | Radiation: intensity modulated radiation therapy in both arms<br> <br> Drug: concurrent chemotherapy with radiation<br>* docetaxel plus cisplatin were used weekly in both arms<br>|
| Active Comparator: standard dose<br>concurrent chemoradiation:CT:DDP 25mg/m2 D1+Docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：50Gy/25F/5W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 5mg/m2 D1+Docetaxel75mg/m2 D1, Q3W | Radiation: intensity modulated radiation therapy in both arms<br> <br> Drug: concurrent chemotherapy with radiation<br>* docetaxel plus cisplatin were used weekly in both arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Carcinoma, chemoradiation, radiation dose