Thymoma and Thymic CarcinomaPhase 2NCT07879417
Phase II Trial of Hypofractionated Radiotherapy Guided by Optical Surface Imaging and Fan-beam CT for Thymoma With Pleural Metastasis
A Phase 2 study testing hypofractionated radiotherapy guided by optical surface imaging and FBCT and hypofractionated radiotherapy guided by CBCT in people with Thymoma and Thymic Carcinoma and Pleural Metastasis, run by Sun Yat-sen University.
Trial summary
This trial plans to conduct a prospective, randomized controlled phase II clinical study to explore the efficacy and safety of hypofractionated radiotherapy guided by optical surface imaging combined with FBCT in patients with thymoma and pleural metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymoma and Thymic Carcinoma, Pleural Metastasis
- What is being tested?
- hypofractionated radiotherapy guided by optical surface imaging and FBCT and hypofractionated radiotherapy guided by CBCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to 12 Oct 2028
- Phase
- Phase 2
- 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
- Histologically confirmed thymoma (type AB, B1-B3, type C).
- Presence of measurable pleural metastatic lesions per RECIST criteria.
- Aged ≥18 and <75 years, no restriction on gender.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- No prior thoracic radiotherapy, immunotherapy or biologic therapy.
- Serum hemoglobin ≥10 g/dL, platelets ≥100,000/μL, absolute neutrophil count (ANC) ≥1,500/μL.
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- Serum creatinine ≤1.25 × upper normal limit (UNL), or creatinine clearance ≥60 mL/min.
- Serum total bilirubin ≤1.5 × UNL; AST (SGOT) and ALT (SGPT) ≤2.5 × UNL; alkaline phosphatase ≤5 × UNL.
- FEV1 >0.8 L.
- CB6 within normal limits.
- The patient and their family agree and provide written informed consent.
Who cannot join
- Prior or concurrent other malignancy at the time of treatment, except for non-melanoma skin cancer or carcinoma in situ of the cervix.
- Presence of uncontrolled comorbidities (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, ongoing immunosuppressive therapy).
- Pregnant or lactating women; females without pregnancy test within 14 days prior to the first administration, and pregnant females.
- Pregnant, lactating individuals, or fertile individuals without effective contraception.
- Subjects with bleeding diathesis.
- Participation in another clinical trial within 30 days prior to enrollment in this study.
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- Individuals with drug addiction such as illicit drug use, chronic alcoholism, or patients with AIDS.
- Uncontrolled seizure disorders or psychiatric illness resulting in impaired capacity for self-care.
- History of severe allergy or idiosyncratic hypersensitivity.
- Subjects whom the investigator considers inappropriate for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Randomized Controlled Phase II Clinical Trial of Hypofractionated Radiotherapy Guided by Optical Surface Imaging and Fan-beam CT for Thymoma With Pleural Metastasis
This trial plans to conduct a prospective, randomized controlled phase II clinical study to explore the efficacy and safety of hypofractionated radiotherapy guided by optical surface imaging combined with FBCT in patients with thymoma and pleural metastasis.
- Conditions
- Thymoma and Thymic Carcinoma, Pleural Metastasis
- Being tested
- hypofractionated radiotherapy guided by optical surface imaging and FBCT, hypofractionated radiotherapy guided by CBCT
- Keywords
- radiotherapy, FBCT
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated radiotherapy guided by optical surface imaging and FBCTDevice
FBCT combined with optical surface imaging is applied to guide and deliver hypofractionated radiotherapy.
hypofractionated radiotherapy guided by CBCTDevice
Conventional CBCT is used to guide and deliver hypofractionated radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | All patients will receive hypofractionated radiotherapy guided by optical surface imaging and FBCT. Receives: Device: hypofractionated radiotherapy guided by optical surface imaging and FBCT |
| The control group | Active comparator | All patients will receive hypofractionated radiotherapy guided by conventional CBCT. Receives: Device: hypofractionated radiotherapy guided by CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of radiation pneumonitis
Radiation pneumonitis are assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 12 months
Secondary outcomes (3)
Progression free survival
Progression-free survival (PFS) is defined as the time from randomization to the first documentation of disease progression or death from any cause, whichever occurs first.
Measured: 2 years
Overall survival
Overall survival (OS) is defined as the time from randomization to death from any cause.
Measured: 2 years
Treatment-related toxicity
Treatment-related adverse events (toxicities) are assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion12 Oct 2028 (estimated)
- Study completion12 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thymoma and Thymic CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879417
- Sponsor's protocol ID
- GASTO-10141
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang CL, Gao LT, Lyu CX, Wang JM, Liu J, Gu HL, Liu Y, Fu XL. Intensity Modulated Radiation Therapy for Pleural Recurrence of Thymoma: A Prospective Phase 2 Study. Int J Radiat Oncol Biol Phys. 2021 Mar 1;109(3):775-782. doi: 10.1016/j.ijrobp.2020.09.058. Epub 2020 Oct 9.
PubMed 33039590Yokoi K, Matsuguma H, Nakahara R, Kondo T, Kamiyama Y, Mori K, Miyazawa N. Multidisciplinary treatment for advanced invasive thymoma with cisplatin, doxorubicin, and methylprednisolone. J Thorac Oncol. 2007 Jan;2(1):73-8. doi: 10.1097/JTO.0b013e31802bafc8.
PubMed 17410014Lucchi M, Mussi A, Basolo F, Ambrogi MC, Fontanini G, Angeletti CA. The multimodality treatment of thymic carcinoma. Eur J Cardiothorac Surg. 2001 May;19(5):566-9. doi: 10.1016/s1010-7940(01)00666-2.
PubMed 11343932Wright CD, Choi NC, Wain JC, Mathisen DJ, Lynch TJ, Fidias P. Induction chemoradiotherapy followed by resection for locally advanced Masaoka stage III and IVA thymic tumors. Ann Thorac Surg. 2008 Feb;85(2):385-9. doi: 10.1016/j.athoracsur.2007.08.051.
PubMed 18222230Gao L, Wang C, Fang W, Zhang J, Lv C, Fu S. Outcome of multimodality treatment for 188 cases of type B3 thymoma. J Thorac Oncol. 2013 Oct;8(10):1329-34. doi: 10.1097/JTO.0b013e31829ceb50.
PubMed 24457243Detterbeck F, Youssef S, Ruffini E, Okumura M. [A review of prognostic factors in thymic malignancies]. Zhongguo Fei Ai Za Zhi. 2014 Feb;17(2):130-6. doi: 10.3779/j.issn.1009-3419.2014.02.11. No abstract available. Chinese.
PubMed 24581164
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Phase II Clinical Trial of Hypofractionated Radiotherapy Guided by Optical Surface Imaging and Fan-beam CT for Thymoma With Pleural Metastasis
- ClinicalTrials.gov ID
- NCT07879417
- Acronym / sponsor ID
- GASTO-10141
- Conditions
- Thymoma and Thymic Carcinoma, Pleural Metastasis
- Keywords
- radiotherapy, FBCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 12 Oct 2028 (estimated)
- Study completion
- 12 Oct 2028 (estimated)
- First posted
- 16 Oct 2026 (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.
This trial plans to conduct a prospective, randomized controlled phase II clinical study to explore the efficacy and safety of hypofractionated radiotherapy guided by optical surface imaging combined with FBCT in patients with thymoma and pleural metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Device: hypofractionated radiotherapy guided by optical surface imaging and FBCTAll patients will receive hypofractionated radiotherapy guided by optical surface imaging and FBCT. |
| The control group | Active comparator | Device: hypofractionated radiotherapy guided by CBCTAll patients will receive hypofractionated radiotherapy guided by conventional CBCT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed thymoma (type AB, B1-B3, type C).
- Presence of measurable pleural metastatic lesions per RECIST criteria.
- Aged ≥18 and <75 years, no restriction on gender.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- No prior thoracic radiotherapy, immunotherapy or biologic therapy.
Key exclusion criteria (10 listed)
- Prior or concurrent other malignancy at the time of treatment, except for non-melanoma skin cancer or carcinoma in situ of the cervix.
- Presence of uncontrolled comorbidities (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, ongoing immunosuppressive therapy).
- Pregnant or lactating women; females without pregnancy test within 14 days prior to the first administration, and pregnant females.
- Pregnant, lactating individuals, or fertile individuals without effective contraception.
- Subjects with bleeding diathesis.
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 |
|---|---|---|
| hypofractionated radiotherapy guided by optical surface imaging and FBCTFBCT combined with optical surface imaging is applied to guide and deliver hypofractionated radiotherapy. | Device | The experimental group |
| hypofractionated radiotherapy guided by CBCTConventional CBCT is used to guide and deliver hypofractionated radiotherapy. | Device | The control group |
Primary outcome
Incidence of radiation pneumonitis
Time frame: 12 months
Radiation pneumonitis are assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
3 secondary outcomes
Progression free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Treatment-related toxicity
Time frame: 12 months
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 Oct 2026.
- Background: PubMed 33039590Wang CL, Gao LT, Lyu CX, Wang JM, Liu J, Gu HL, Liu Y, Fu XL. Intensity Modulated Radiation Therapy for Pleural Recurrence of Thymoma: A Prospective Phase 2 Study. Int J Radiat Oncol Biol Phys. 2021 Mar 1;109(3):775-782. doi: 10.1016/j.ijrobp.2020.09.058. Epub 2020 Oct 9.
- Background: PubMed 17410014Yokoi K, Matsuguma H, Nakahara R, Kondo T, Kamiyama Y, Mori K, Miyazawa N. Multidisciplinary treatment for advanced invasive thymoma with cisplatin, doxorubicin, and methylprednisolone. J Thorac Oncol. 2007 Jan;2(1):73-8. doi: 10.1097/JTO.0b013e31802bafc8.
- Background: PubMed 11343932Lucchi M, Mussi A, Basolo F, Ambrogi MC, Fontanini G, Angeletti CA. The multimodality treatment of thymic carcinoma. Eur J Cardiothorac Surg. 2001 May;19(5):566-9. doi: 10.1016/s1010-7940(01)00666-2.
- Background: PubMed 18222230Wright CD, Choi NC, Wain JC, Mathisen DJ, Lynch TJ, Fidias P. Induction chemoradiotherapy followed by resection for locally advanced Masaoka stage III and IVA thymic tumors. Ann Thorac Surg. 2008 Feb;85(2):385-9. doi: 10.1016/j.athoracsur.2007.08.051.
- Background: PubMed 24457243Gao L, Wang C, Fang W, Zhang J, Lv C, Fu S. Outcome of multimodality treatment for 188 cases of type B3 thymoma. J Thorac Oncol. 2013 Oct;8(10):1329-34. doi: 10.1097/JTO.0b013e31829ceb50.
- Background: PubMed 24581164Detterbeck F, Youssef S, Ruffini E, Okumura M. [A review of prognostic factors in thymic malignancies]. Zhongguo Fei Ai Za Zhi. 2014 Feb;17(2):130-6. doi: 10.3779/j.issn.1009-3419.2014.02.11. No abstract available. Chinese.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hypofractionated radiotherapy guided by optical surface imaging and FBCT and hypofractionated radiotherapy guided by CBCT in people with Thymoma and Thymic Carcinoma and Pleural Metastasis, run by Sun Yat-sen University.
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 11 inclusion and 10 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 DaQuan Wang (+862087343031, wangdq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of radiation pneumonitis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07879417, which also lists 6 linked publications.
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 Oct 2026.