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Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02633553
Collaborator
(none)
238
Enrollment
1
Location
2
Arms
142.7
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: adjuvant radiotherapy
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
238 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
Actual Study Start Date :
Jan 10, 2018
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: radiotherapy group

complete resection and adjuvant radiotherapy

Radiation: adjuvant radiotherapy
50Gy/25Fx
Other Names:
  • RT

    		•
    No Intervention: observation group

    complete resection

    Outcome Measures

    Primary Outcome Measures

    1. DFS (Disease free survival) [5 years]

      from registration to disease progression or death.

    Secondary Outcome Measures

    1. OS(overall survival) [5 years]

      from registration to death

    2. Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0 [5 years]

      Adverse Events Assessed by CTCAE v4.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kailiang Wu Shanghai Shanghai China 20032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kailiang Wu, professor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT02633553
    Other Study ID Numbers:
    • 1508151-4
    First Posted:
    Dec 17, 2015
    Last Update Posted:
    Jan 15, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kailiang Wu, professor, Fudan University
    thymoma
    adjuvant radiotherapy
    complete resection
    Additional relevant MeSH terms:
    Thymoma
    Thymus Neoplasms

    Study Results

    No Results Posted as of Jan 15, 2019