- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02636556
Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 20032
- Kailiang Wu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1.18~75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent.
Exclusion Criteria:
- Distant metastases could not be encompassed within a tolerable radiotherapy field;
- Underwent surgery, radiotherapy or chemotherapy before entering this study ;
- Have other malignancy history excluding carcinoma in situ of cervix in the previous five years;
- Active clinical pulmonary infection;
- Pregnant or nursing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: chemoradiation
concurrent chemoradiation.
|
The patients receive chemotherapy concurrent with Radiotherapy.
The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w*4.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: 3 months after treatment
|
Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria
|
3 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 2 years
|
from registration to death as a result of any cause.
|
2 years
|
Progression free survival
Time Frame: 2 years
|
from registration to first documentation of disease progression or death.
|
2 years
|
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: up to 2 years
|
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
|
up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kailiang Wu, M.D.,Ph.D, Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1508151-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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