Back to resultsAdjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
Primary Purpose
Thymoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
adjuvant radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Thymoma focused on measuring thymoma, adjuvant radiotherapy, complete resection
Eligibility Criteria
Inclusion Criteria:
18~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed masaoka stage II or III thymoma; Have adequate bone marrow, hepatic, and renal function; Patients receive complete resection within 3 months; Written informed consent.
Exclusion Criteria:
Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.
Sites / Locations
- Kailiang WuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
radiotherapy group
observation group
Arm Description
complete resection and adjuvant radiotherapy
complete resection
Outcomes
Primary Outcome Measures
DFS (Disease free survival)
from registration to disease progression or death.
Secondary Outcome Measures
OS(overall survival)
from registration to death
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
Adverse Events Assessed by CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02633553
Brief Title
Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
Official Title
An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma.
Detailed Description
It is confirmed by many studies that patients of thymoma with complete resection have better prognosis than those with either incomplete resection or without surgery. However,whether patients with stage II or III thymoma could benefit from adjuvant radiotherapy after complete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiotherapy after complete resection can improve survival for stage II or III thymoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma
Keywords
thymoma, adjuvant radiotherapy, complete resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radiotherapy group
Arm Type
Experimental
Arm Description
complete resection and adjuvant radiotherapy
Arm Title
observation group
Arm Type
No Intervention
Arm Description
complete resection
Intervention Type
Radiation
Intervention Name(s)
adjuvant radiotherapy
Other Intervention Name(s)
RT
Intervention Description
50Gy/25Fx
Primary Outcome Measure Information:
Title
DFS (Disease free survival)
Description
from registration to disease progression or death.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
OS(overall survival)
Description
from registration to death
Time Frame
5 years
Title
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
Description
Adverse Events Assessed by CTCAE v4.0
Time Frame
5 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:
18~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed masaoka stage II or III thymoma; Have adequate bone marrow, hepatic, and renal function; Patients receive complete resection within 3 months; Written informed consent.
Exclusion Criteria:
Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kailiang Wu, MD.PhD.
Phone
+86 64175590
Ext
86722
Email
wukailiang@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xingwen Fan, MD
Phone
+8613651669687
Email
wenxingfan@126.com
Facility Information:
Facility Name
Kailiang Wu
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kailiang Wu, M.D. Ph. D.
Phone
+86 64175590
Ext
86722
Email
wukailiang@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
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