Back to resultsComparable Study of Different Radiation Dose in Esophageal Carcinoma
Primary Purpose
Esophageal Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
intensity modulated radiation therapy in both arms
concurrent chemotherapy with radiation
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Carcinoma focused on measuring Esophageal Carcinoma, chemoradiation, radiation dose
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
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high-dose
standard dose
Arm 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
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
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Overall survival
Full Information
NCT ID
NCT01937208
First Posted
August 25, 2013
Last Updated
September 3, 2013
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01937208
Brief Title
Comparable Study of Different Radiation Dose in Esophageal Carcinoma
Official Title
A Prospective, Randomised Phase 3 Study of High-dose Versus Standard-dose Radiation of Inoperable Esophageal Carcinoma Treated With Concurrent Chemoradiation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma
Keywords
Esophageal Carcinoma, chemoradiation, radiation dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high-dose
Arm Type
Experimental
Arm 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
Arm Title
standard dose
Arm Type
Active Comparator
Arm 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
Intervention Type
Radiation
Intervention Name(s)
intensity modulated radiation therapy in both arms
Intervention Type
Drug
Intervention Name(s)
concurrent chemotherapy with radiation
Intervention Description
docetaxel plus cisplatin were used weekly in both arms
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
local control rate; relapse location; toxicity
Time Frame
5 years
Title
radiation-related advent events
Time Frame
at least 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiao zheng, MD
Phone
0086-571-88122078
Email
zhengxiao@medmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ming chen, PHD
Phone
0086-571-88122068
Email
chenming@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Zheng, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiao zheng, MD
Phone
0086-571-88122078
Email
zhengxiao@medmail.com
First Name & Middle Initial & Last Name & Degree
ming chen, PHD
12. IPD Sharing Statement
Learn more about this trial
Comparable Study of Different Radiation Dose in Esophageal Carcinoma
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