To hear about similar clinical trials, please enter your email below

Trial Title: Comparable Study of Different Radiation Dose in Esophageal Carcinoma

NCT ID: NCT01937208

Condition: Esophageal Carcinoma

Conditions: Official terms:
Carcinoma
Esophageal Neoplasms

Conditions: Keywords:
Esophageal Carcinoma
chemoradiation
radiation dose

Study type: Interventional

Study phase: Phase 3

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: intensity modulated radiation therapy in both arms
Arm group label: high-dose
Arm group label: standard dose

Intervention type: Drug
Intervention name: concurrent chemotherapy with radiation
Description: docetaxel plus cisplatin were used weekly in both arms
Arm group label: high-dose
Arm group label: standard dose

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.

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: xiao zheng, MD

Phone: 0086-571-88122078
Email: zhengxiao@medmail.com

Investigator:
Last name: ming chen, PHD
Email: Principal Investigator

Start date: August 2013

Completion date: July 2017

Lead sponsor:
Agency: Zhejiang Cancer Hospital
Agency class: Other

Source: Zhejiang Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01937208

Login to your account

Did you forget your password?