ThymomaNCT02633553
Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
A study testing adjuvant radiotherapy in people with Thymoma, run by Fudan University at 1 site in China.
Trial summary
This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymoma
- What is being tested?
- adjuvant radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2018to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Kailiang Wu
Shanghai, Shanghai Municipality, 20032
Kailiang Wu, M.D. Ph. D., +86 64175590 ext. 86722, wukailiang@aliyun.com
About this study
Official title: An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma.
Read the 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.
- Conditions
- Thymoma
- Being tested
- adjuvant radiotherapy
- Keywords
- thymoma, adjuvant radiotherapy, complete resection
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant radiotherapyRadiation
Also called RT
50Gy/25Fx
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy group | Experimental | complete resection and adjuvant radiotherapy Receives: Radiation: adjuvant radiotherapy |
| observation group | No intervention | complete resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS (Disease free survival)
from registration to disease progression or death.
Measured: 5 years
Secondary outcomes (2)
OS(overall survival)
from registration to death
Measured: 5 years
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
Adverse Events Assessed by CTCAE v4.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start10 Jan 2018
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThymomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kailiang Wu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633553
- Sponsor's protocol ID
- 1508151-4
- Status last verified
- Apr 2026
- First submitted
- 15 Dec 2015
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
- ClinicalTrials.gov ID
- NCT02633553
- Acronym / sponsor ID
- 1508151-4
- Conditions
- Thymoma
- Keywords
- thymoma, adjuvant radiotherapy, complete resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiotherapy group | Experimental | Radiation: adjuvant radiotherapycomplete resection and adjuvant radiotherapy |
| observation group | No intervention | –complete resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adjuvant radiotherapyAlso: RT50Gy/25Fx | Radiation | radiotherapy group |
Primary outcome
DFS (Disease free survival)
Time frame: 5 years
from registration to disease progression or death.
2 secondary outcomes
OS(overall survival)
Time frame: 5 years
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adjuvant radiotherapy in people with Thymoma, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kailiang Wu, MD.PhD. (+86 64175590 ext. 86722, wukailiang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (Disease free survival) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.