NCT02633553

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2018Dec 2029

First Submitted

Initial submission to the registry

December 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

11.9 years

First QC Date

December 15, 2015

Last Update Submit

April 22, 2026

Conditions

Thymoma

Keywords

thymomaadjuvant radiotherapycomplete resection

Outcome Measures

Primary Outcomes (1)

  • DFS (Disease free survival)

    from registration to disease progression or death.

    5 years

Secondary Outcomes (2)

  • OS(overall survival)

    5 years

  • Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0

    5 years

Study Arms (2)

radiotherapy group

EXPERIMENTAL

complete resection and adjuvant radiotherapy

Radiation: adjuvant radiotherapy

observation group

NO INTERVENTION

complete resection

Interventions

adjuvant radiotherapyRADIATION

50Gy/25Fx

Also known as: RT
radiotherapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kailiang Wu

Shanghai, Shanghai Municipality, 20032, China

RECRUITING

MeSH Terms

Conditions

Thymoma

Interventions

Radiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsRadiotherapy

Central Study Contacts

Kailiang Wu, MD.PhD.

CONTACT

+86 64175590wukailiang@aliyun.com

Xingwen Fan, MD

CONTACT

+8613651669687wenxingfan@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 17, 2015

Study Start

January 10, 2018

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

CN(1)