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Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

NCT ID: NCT02633553

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2029-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Thymoma

Keywords

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thymoma adjuvant radiotherapy complete resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiotherapy group

complete resection and adjuvant radiotherapy

Group Type EXPERIMENTAL

adjuvant radiotherapy

Intervention Type RADIATION

50Gy/25Fx

observation group

complete resection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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adjuvant radiotherapy

50Gy/25Fx

Intervention Type RADIATION

Other Intervention Names

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RT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Kailiang Wu

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kailiang Wu

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kailiang Wu, MD.PhD.

Role: CONTACT

Phone: +86 64175590

Email: [email protected]

Xingwen Fan, MD

Role: CONTACT

Phone: +8613651669687

Email: [email protected]

Facility Contacts

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Kailiang Wu, M.D. Ph. D.

Role: primary

Other Identifiers

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1508151-4

Identifier Type: -

Identifier Source: org_study_id