Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

Fudan University

Status: Enrolling

Conditions: Thymoma

Treatments: Radiation: adjuvant radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02633553

1508151-4

Details and patient eligibility

About

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

Full 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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

radiotherapy group

Experimental group

Description:

complete resection and adjuvant radiotherapy

Treatment:

Radiation: adjuvant radiotherapy

observation group

No Intervention group

Description:

complete resection