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Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02633553
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Kailiang Wu, Fudan University

Study Description
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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
Thymoma 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 10, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: radiotherapy group
complete resection and adjuvant radiotherapy
 Radiation: adjuvant radiotherapy
50Gy/25Fx
Other Name: RT
No Intervention: observation group
complete resection


Outcome Measures
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Primary Outcome Measures :
  1. DFS (Disease free survival) [ Time Frame: 5 years ]
    from registration to disease progression or death.


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633553


Contacts
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Contact: Kailiang Wu, MD.PhD. +86 64175590 ext 86722 wukailiang@aliyun.com
Contact: Xingwen Fan, MD +8613651669687 wenxingfan@126.com

Locations
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China, Shanghai
Kailiang Wu Recruiting
Shanghai, Shanghai, China, 20032
Contact: Kailiang Wu, M.D. Ph. D.    +86 64175590 ext 86722    wukailiang@aliyun.com   
Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: Kailiang Wu, professor, Fudan University
ClinicalTrials.gov Identifier: NCT02633553    
Other Study ID Numbers: 1508151-4
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kailiang Wu, Fudan University:
thymoma
adjuvant radiotherapy
complete resection
Additional relevant MeSH terms:
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Thymoma
Thymus Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
 Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases