Combining glucocorticoids with chemoradiotherapy for thymoma treatment
A Prospective, Single-arm Phase II Study of Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma
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 |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT06730308 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed type AB or B1-3 thymoma and measurable disease.
Not a fit: Patients with contraindications to methylprednisolone or those with concurrent malignancies may not benefit from this study.
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 performed: While this approach is novel in the context of thymoma, similar combinations of glucocorticoids with chemoradiotherapy have shown promise in other cancers.
Eligibility criteria
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 this trial is running
Guanzhou, Guangdong
- Sun yat-sen University Cancer Center — Guanzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.