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Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

Not Applicable
Recruiting
Conditions
Thymoma
Registration Number
NCT02633553
Lead Sponsor
Fudan University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
238
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
DFS (Disease free survival)5 years

from registration to disease progression or death.

Secondary Outcome Measures
NameTimeMethod
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.05 years

Adverse Events Assessed by CTCAE v4.0

OS(overall survival)5 years

from registration to death

Trial Locations

Locations (1)

Kailiang Wu

🇨🇳

Shanghai, Shanghai, China

Kailiang Wu
🇨🇳Shanghai, Shanghai, China
Kailiang Wu, M.D. Ph. D.
Contact
+86 64175590
wukailiang@aliyun.com

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