Adjuvant Radiotherapy for Stage II/III Thymoma After Comp... | NCT02633553

Studies
Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

NCT02633553

Sponsor

Fudan University

Status

Recruiting

Last Update Posted

Apr 24, 2026Actual

Enrollment

238Estimated

Phase

Not Applicable

Conditions

Thymoma

Interventions

adjuvant radiotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2018Actual

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Dec 15, 2015

First Submission Date that Met QC Criteria

Dec 15, 2015

First Posted Date

Dec 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

238Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
radiotherapy group	Experimental	complete resection and adjuvant radiotherapy	Radiation: adjuvant radiotherapy
observation group	No Intervention	complete resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
adjuvant radiotherapy	Radiation	50Gy/25Fx	radiotherapy group	RT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DFS (Disease free survival)	from registration to disease progression or death.	5 years

Secondary Outcomes

Measure	Description	Time Frame
OS(overall survival)	from registration to death	5 years
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0	Adverse Events Assessed by CTCAE v4.0

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kailiang Wu, MD.PhD.	Contact	+86 64175590	86722	wukailiang@aliyun.com
Xingwen Fan, MD	Contact	+8613651669687		wenxingfan@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kailiang Wu	Recruiting	Shanghai	Shanghai Municipality	20032	China

Condition Browse Module

MeSH Terms

ID	Term
D013945	Thymoma

Ancestor Terms

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D013953	Thymus Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018714	Radiotherapy, Adjuvant

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D011878	Radiotherapy

Browse Leaves

Not provided

Browse Branches

Not provided