ThymomaPhase 2NCT06730308
Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma
A Phase 2 study testing Radiotherapy, Concurrent chemotherapy and Methylprednisolone in people with Thymoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent 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?
- Radiotherapy, Concurrent chemotherapy and Methylprednisolone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 19 Nov 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 type AB or B1-3 thymoma.
- Measurable Disease: Patients must have measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors).
- Unresectable or recurrent thymoma, with the tumor confined to the chest and neck area.
- Between the ages of 18 and 70 years, regardless of sex.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- No prior chest radiation.
- Adequate organ Functions.
- Written informed consent obtained.
Who cannot join
- Contraindications to Methylprednisolone.
- History of or Concurrent Malignancy.
- Active infection, myocardial infarction within the last 6 months or symptomatic heart disease.
- Pregnant or Lactating Women.
- Bleeding Disorders.
- Recent Participation in Other Clinical Trials.
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- Drug Abuse or Severe Alcoholism.
- Uncontrolled Seizures or Mental Disorders.
- Severe Allergies or Specific Sensitivities.
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
Sun yat-sen University Cancer Center
Guanzhou, Guangdong, 510000
Bo Qiu, 862087343031, qiubo@sysucc.org.cn
About this study
Official title: A Prospective, Single-arm Phase II Study of Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma
This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma.
Read the detailed description
This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma. Patients will receive hypofractionated radiotherapy with concurrent chemotherapy.
Methylprednisolone will be administered daily during radiotherapy at a dose of 2 mg/kg.
- Conditions
- Thymoma
- Being tested
- Radiotherapy, Concurrent chemotherapy, Methylprednisolone
- Keywords
- Thymoma, Concurrent chemoradiotherapy, Methylprednisolone
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Hypofractionated radiotherapy
Concurrent chemotherapyDrug
weekly albumin-bound paclitaxel (50 mg/m²) and cisplatin (25 mg/m²)
Methylprednisolone 2mg/kg, qd, concurrent with radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Methylprednisolone combined with concurrent chemoradiotherapy Receives: Radiation: Radiotherapy; Drug: Concurrent chemotherapy; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The percentage of patients who achieve complete remission or partial remission after chemoradiotherapy
Measured: 1-2 months after chemoradiotherapy
Secondary outcomes (4)
Progression-free survival
From the start date of initial treatment to progression, death or last follow-up
Measured: 2-year
Overall survival
From the start date of initial treatment to death or to last follow-up.
Measured: 2-year
Toxicities using the CTCAE 5.0
Toxicities were evaluated using the CTCAE 5.0
Measured: 1 year after treatment
Quality of life scores
Quality of life assessed by QLQ-C30
Measured: 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start20 Nov 2024
- Primary completion19 Nov 2028 (estimated)
- Study completion19 Nov 2028 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT06730308
- Sponsor's protocol ID
- GASTO10106
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Phase II Study of Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma
- ClinicalTrials.gov ID
- NCT06730308
- Acronym / sponsor ID
- GASTO10106
- Conditions
- Thymoma
- Keywords
- Thymoma, Concurrent chemoradiotherapy, Methylprednisolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 19 Nov 2028 (estimated)
- Study completion
- 19 Nov 2028 (estimated)
- First posted
- 12 Dec 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.
This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma.
Detailed description
This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma. Patients will receive hypofractionated radiotherapy with concurrent chemotherapy.
Methylprednisolone will be administered daily during radiotherapy at a dose of 2 mg/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Radiation: Radiotherapy, Drug: Concurrent chemotherapy, Drug: MethylprednisoloneMethylprednisolone combined with concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed type AB or B1-3 thymoma.
- Measurable Disease: Patients must have measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors).
- Unresectable or recurrent thymoma, with the tumor confined to the chest and neck area.
- Between the ages of 18 and 70 years, regardless of sex.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Key exclusion criteria (9 listed)
- Contraindications to Methylprednisolone.
- History of or Concurrent Malignancy.
- Active infection, myocardial infarction within the last 6 months or symptomatic heart disease.
- Pregnant or Lactating Women.
- Bleeding Disorders.
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 |
|---|---|---|
| RadiotherapyHypofractionated radiotherapy | Radiation | Study arm |
| Concurrent chemotherapyweekly albumin-bound paclitaxel (50 mg/m²) and cisplatin (25 mg/m²) | Drug | Study arm |
| MethylprednisoloneMethylprednisolone 2mg/kg, qd, concurrent with radiotherapy | Drug | Study arm |
Primary outcome
Objective response rate
Time frame: 1-2 months after chemoradiotherapy
The percentage of patients who achieve complete remission or partial remission after chemoradiotherapy
4 secondary outcomes
Progression-free survival
Time frame: 2-year
Overall survival
Time frame: 2-year
Toxicities using the CTCAE 5.0
Time frame: 1 year after treatment
Quality of life scores
Time frame: 1 year after treatment
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 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing Radiotherapy, Concurrent chemotherapy and Methylprednisolone in people with Thymoma, run by Sun Yat-sen 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 8 inclusion and 9 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 12 Dec 2024. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 1-2 months after chemoradiotherapy). 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 12 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.