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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
