Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

Thymoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02633553
• Other study ID #: 1508151-4
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: December 2029

Study information

• Verified date: December 2023
• Source: Fudan University
• Contact: Kailiang Wu, MD.PhD.
• Phone: +86 64175590
• Email: wukailiang[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma.

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 information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: December 2029
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thymoma
• Thymus Neoplasms

Intervention

Radiation:
• adjuvant radiotherapy
50Gy/25Fx

Locations

Country	Name	City	State
China	Kailiang Wu	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS (Disease free survival)	from registration to disease progression or death.	5 years
Secondary	OS(overall survival)	from registration to death	5 years
Secondary	Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0	Adverse Events Assessed by CTCAE v4.0	5 years