Comparable Study of Different Radiation Dose in Esophageal Carcinoma

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 3

Conditions: Esophageal Carcinoma

Treatments: Drug: concurrent chemotherapy with radiation; Radiation: intensity modulated radiation therapy in both arms

Study type: Interventional

Funder types: Other

Identifiers

NCT01937208

ESC-130825

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

high-dose

Experimental group

Description:

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

Treatment:

Radiation: intensity modulated radiation therapy in both arms

Drug: concurrent chemotherapy with radiation

standard dose

Active Comparator group

Description:

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

Treatment:

Radiation: intensity modulated radiation therapy in both arms

Drug: concurrent chemotherapy with radiation