Back to resultsChemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Primary Purpose
Thymoma and Thymic Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
concurrent chemoradiation
Sponsored by
About this trial
This is an interventional treatment trial for Thymoma and Thymic Carcinoma focused on measuring thymoma, thymic carcinoma, chemoradiotherapy, inoperable
Eligibility Criteria
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.
Sites / Locations
- Kailiang Wu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chemoradiation
Arm Description
concurrent chemoradiation.
Outcomes
Primary Outcome Measures
Objective response rate
Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria
Secondary Outcome Measures
Overall survival
from registration to death as a result of any cause.
Progression free survival
from registration to first documentation of disease progression or death.
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02636556
Brief Title
Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Official Title
Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.
Detailed Description
Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma and Thymic Carcinoma
Keywords
thymoma, thymic carcinoma, chemoradiotherapy, inoperable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intensity modulated radiotherapy with VP-16/Cisplatin
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chemoradiation
Arm Type
Experimental
Arm Description
concurrent chemoradiation.
Intervention Type
Radiation
Intervention Name(s)
concurrent chemoradiation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate
Description
Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Overall survival
Description
from registration to death as a result of any cause.
Time Frame
2 years
Title
Progression free survival
Description
from registration to first documentation of disease progression or death.
Time Frame
2 years
Title
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Description
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kailiang Wu, M.D.,Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kailiang Wu
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
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