Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

Not Applicable

Recruiting

• Conditions: Thymoma
• Interventions: Radiation: adjuvant radiotherapy

• 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.

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-17
• Study Start: 2018-01-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-08
• Primary Completion: 2025-12
• Study Completion: 2029-12

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

Arm && Interventions

Group	Intervention	Description
radiotherapy group	adjuvant radiotherapy	complete resection and adjuvant radiotherapy

Primary Outcome Measures

Name	Time	Method
DFS (Disease free survival)	5 years	from registration to disease progression or death.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kailiang Wu; 🇨🇳 Shanghai, Shanghai, China