Combining glucocorticoids with chemoradiotherapy for thymoma treatment
Official title: A Prospective, Single-arm Phase II Study of Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma
Run by Sun Yat-sen University · NCT06730308 · Data updated 2026-11-12
This study is testing if adding a steroid called methylprednisolone to standard chemotherapy and radiation can help people with advanced or recurring thymoma have better treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Guanzhou, Guangdong) |
| Status | Recruiting |
| Started | November 20, 2024 |
| Main results expected | November 19, 2028 |
| Study ends | November 19, 2028 |
| Registry record updated | December 12, 2024 |
| Trial ID | NCT06730308 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 70 with histologically confirmed type AB or B1-3 thymoma and measurable disease.
✕Probably not a fit
Patients with contraindications to methylprednisolone or those with concurrent malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of methylprednisolone when used alongside concurrent chemoradiotherapy in patients with unresectable or recurrent thymoma. Participants will receive hypofractionated radiotherapy combined with chemotherapy, while methylprednisolone will be administered daily during the treatment at a dose of 2 mg/kg. The goal is to determine if this combination improves treatment outcomes for patients with this specific type of cancer.
Why it matters
Potential benefit: If successful, this approach could enhance treatment efficacy and improve survival rates for patients with unresectable thymoma.
How similar studies have gone: While this approach is novel in the context of thymoma, similar combinations of glucocorticoids with chemoradiotherapy have shown promise in other cancers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Drug Abuse or Severe Alcoholism. * Uncontrolled Seizures or Mental Disorders. * Severe Allergies or Specific Sensitivities.
Where it's running
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Sun yat-sen University Cancer Center
Guanzhou, Guangdong, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.