Thymoma
Conditions
Keywords
Thymoma, Concurrent chemoradiotherapy, Methylprednisolone
Brief summary
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.
Interventions
RADIATIONRadiotherapy
Hypofractionated radiotherapy
DRUGConcurrent chemotherapy
weekly albumin-bound paclitaxel (50 mg/m²) and cisplatin (25 mg/m²)
DRUGMethylprednisolone
Methylprednisolone 2mg/kg, qd, concurrent with radiotherapy
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 1-2 months after chemoradiotherapy | The percentage of patients who achieve complete remission or partial remission after chemoradiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2-year | From the start date of initial treatment to progression, death or last follow-up |
| Overall survival | 2-year | From the start date of initial treatment to death or to last follow-up. |
| Toxicities using the CTCAE 5.0 | 1 year after treatment | Toxicities were evaluated using the CTCAE 5.0 |
| Quality of life scores | 1 year after treatment | Quality of life assessed by QLQ-C30 |
Countries
China
Outcome results
None listed