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NCT Number: NCT02633553

Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

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

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Key information

Conditions

Thymoma Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Thoracic Neoplasms Thymus Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kailiang Wu

Shanghai, Shanghai Municipality, 20032, China

Location status: Recruiting

Location contact

Kailiang Wu, M.D. Ph. D.

CONTACT

[email protected]

+86 64175590 ext. 86722

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adjuvant radiotherapy

Radiation

50Gy/25Fx

Other names: RT

Primary outcomes

  1. DFS (Disease free survival)

    Time frame: 5 years

    from registration to disease progression or death.

Secondary outcomes

  1. OS(overall survival)

    Time frame: 5 years

    from registration to death

  2. Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0

    Time frame: 5 years

    Adverse Events Assessed by CTCAE v4.0

Study contacts

Contact information is provided by the study sponsor or research team.

Kailiang Wu, MD.PhD.

CONTACT

[email protected]

+86 64175590 ext. 86722

Xingwen Fan, MD

CONTACT

[email protected]

+8613651669687

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2029
Study completion
2029
First posted
Dec 17, 2015
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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