Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02633553

Enrollment

238

Registered

2015-12-17

Start date

2018-01-10

Completion date

2029-12-01

Last updated

2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thymoma

Keywords

thymoma, adjuvant radiotherapy, complete resection

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.

Interventions

RADIATIONadjuvant radiotherapy

50Gy/25Fx

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
DFS (Disease free survival)	5 years	from registration to disease progression or death.

Secondary

Measure	Time frame	Description
OS(overall survival)	5 years	from registration to death
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0	5 years	Adverse Events Assessed by CTCAE v4.0

Countries

China

Contacts

CONTACTKailiang Wu, MD.PhD.

wukailiang@aliyun.com+86 64175590

CONTACTXingwen Fan, MD

wenxingfan@126.com+8613651669687

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026