Thymus NeoplasmsNCT06189183
Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection
A study testing Adjuvant Hypofractionation Radiotherapy in people with Thymus Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymus Neoplasms
- What is being tested?
- Adjuvant Hypofractionation Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2023to 31 Dec 2040
- 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
- Thymoma and Thymic carcinoma confirmed by histology or cytology
- R0 resection (complete resection)
- stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.
- Karnofsky performance status(KPS) 80, 90 or 100.
- Having sufficient Pulmonary function, renal function and liver function. Neutrophile granulocyte count>1.5×109 /L, platelet count>80×109 /L, hemoglobin ≥10g/dL.
Who cannot join
- Prior thoracic radiotherapy.
- Uncontrolled Comorbidities.
- Pregnant or nursing mother.
- Pneumonia
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100021
About this study
Official title: Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection-Single Center Phase II Single Arm Clinical Trial
The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.
Read the detailed description
Adjuvant Radiotherapy(Postoperative radiotherapy) is proposed in stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.
Hypofractionation Radiotherapy is used in this study. The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.
- Conditions
- Thymus Neoplasms
- Being tested
- Adjuvant Hypofractionation Radiotherapy
- Keywords
- Thymus Neoplasms, Adjuvant Radiotherapy
- Medical subject headings
- Thymus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant Hypofractionation RadiotherapyRadiation
Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Hypofractionation Radiotherapy | Experimental | Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection Receives: Radiation: Adjuvant Hypofractionation Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
From the date of resection to the date of disease recurrence or death
Measured: 2 years, 5 years
Secondary outcomes (5)
Overall Survival
From the date of resection to the date of death
Measured: 2 years, 5 years
RadiotherapyToxicity
Rate of pneumonitis；Rate of esophagitis；Rate of skin reaction；Rate of myelitis；Rate of heart disease；Rate of vascular toxicity
Measured: 1 years, 2 years, 5 years
local recurrence
recurrence of tumor bed
Measured: 2 years, 5 years
Intrathoracic recurrence / pleural metastasis
Rate of Intrathoracic recurrence / pleural metastasis
Measured: 2 years, 5 years
metastasis free survival
From the date of resection to the date of metastasis or death
Measured: 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start11 Nov 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymus NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Zhang, Dr., Principal investigator, National Cancer Center/Cancer Hospital, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189183
- Sponsor's protocol ID
- NCC4287
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection-Single Center Phase II Single Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT06189183
- Acronym / sponsor ID
- NCC4287
- Conditions
- Thymus Neoplasms
- Keywords
- Thymus Neoplasms, Adjuvant Radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 3 Jan 2024 (actual)
- 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.
The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.
Detailed description
Adjuvant Radiotherapy(Postoperative radiotherapy) is proposed in stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.
Hypofractionation Radiotherapy is used in this study. The purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Hypofractionation Radiotherapy | Experimental | Radiation: Adjuvant Hypofractionation RadiotherapyAdjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Thymoma and Thymic carcinoma confirmed by histology or cytology
- R0 resection (complete resection)
- stage II and III thymic carcinoma，stage III thymoma，stage IIB B2/B3 thymomas.
- Karnofsky performance status(KPS) 80, 90 or 100.
- Having sufficient Pulmonary function, renal function and liver function. Neutrophile granulocyte count>1.5×109 /L, platelet count>80×109 /L, hemoglobin ≥10g/dL.
Key exclusion criteria (4 listed)
- Prior thoracic radiotherapy.
- Uncontrolled Comorbidities.
- Pregnant or nursing mother.
- Pneumonia
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 Hypofractionation RadiotherapyAdjuvant Hypofractionation Radiotherapy for Thymic Epithelial Tumours After Complete Resection | Radiation | Adjuvant Hypofractionation Radiotherapy |
Primary outcome
Disease Free Survival
Time frame: 2 years, 5 years
From the date of resection to the date of disease recurrence or death
5 secondary outcomes
Overall Survival
Time frame: 2 years, 5 years
RadiotherapyToxicity
Time frame: 1 years, 2 years, 5 years
local recurrence
Time frame: 2 years, 5 years
Intrathoracic recurrence / pleural metastasis
Time frame: 2 years, 5 years
metastasis free survival
Time frame: 2 years, 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 16 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tao Zhang, Dr. principal investigator
National Cancer Center/Cancer Hospital, CAMS
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 Hypofractionation Radiotherapy in people with Thymus Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (time frame: 2 years, 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 16 Jun 2026.