thymoma
Conditions
Interventions
Glucocorticoid therapy group:Oral methylprednisolone 0.6mg/kg/d
Standard chemotherapy group:Cisplatin 50 mg/m2 IV day 1
Doxorubicin 50 mg/m2 IV day 1
Cyclophosphamide 500 mg/m2 IV day 1
Administered every 3 weeks
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years and =75 years; 2. Anterior mediastinal tumors with clinical stage III or IV that are not expected to achieve R0 resection; 3. The pathologic diagnosis was thymoma by core needle biopsy before operation; 4. Subjects are fully aware of the trial protocol, voluntarily participate in the clinical study, and sign informed consent; 5. Patients who failed or could not tolerate standard treatment. (Tumor volume reduction of 30% assessed by CT and maintained for at least 6 weeks was defined as effective, therwise it was noneffective.)
Exclusion criteria
Exclusion criteria: 1.Patients with high risk of glucocorticoid use, such as glucocorticoid allergy, systemic infection, poorly controlled diabetes, severe hypertension, and digestiveulcer; 2.Patients with pregnancy, lactation, bone marrow suppression, serious heart disease,and chemotherapy drug allergy of this research; 3.Combined with other malignant or borderline tumors; 4.Combined with insufficiency of vital organs; 5.Take drugs such as immunosuppressants that have a possible or definite therapeutic effect on thymoma; 6.Vulnerable groups with mental disorders, disabilities, involuntary behavior and judgment; 7.Patients who were deemed unfit to participate in the study by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete resection rate;Quality of Life;Progression-free survival rate of 5-year ;Overall survival rate of 5-year;Distribution and difference of cell subsets and glucocorticoid receptors in blood and tumor tissues of patients with glucocorticoid-sensitive and insensitive thymoma before/after treatment;Distribution and difference of cell subsets and glucocorticoid receptors in blood and tumor tissues before/after treatment between glucocorticoid treatment group and standard chemotherapy group; | — |
Countries
China
Contacts
Public ContactLei Yu
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed