Actively Recruiting
A Prospective, Single-arm Phase II Study of Methylprednisolone Combined With Concurrent Chemoradiotherapy for Unresectable or Recurrent Thymoma
Led by Sun Yat-sen University · Updated on 2024-12-12
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial investigates the use of methylprednisolone combined with concurrent chemoradiotherapy to treat patients with unresectable or recurrent thymoma confined to the chest and neck area. The study focuses on patients diagnosed with specific types of thymoma (type AB or B1-3) who have measurable disease and meet certain health and age criteria. The trial aims to evaluate how well this combined treatment works in managing the disease. Participants will receive hypofractionated radiotherapy along with weekly chemotherapy using albumin-bound paclitaxel and cisplatin. Alongside these treatments, methylprednisolone will be given daily at a dose of 2 mg per kg of body weight throughout the radiotherapy period. This approach is designed to assess the treatment combination's effect on thymoma in a single-arm, phase II study. During the study, participants will be monitored for tumor response one to two months after treatment, as well as progression-free survival, overall survival, treatment-related toxicities, and quality of life over a two-year and one-year period, respectively. Researchers will conduct various assessments including clinical evaluations and safety monitoring to gather data on the treatment's impact and side effects. Total participation length and follow-up will extend for at least two years post-treatment.
CONDITIONS
Brief Title
Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed type AB or B1-3 thymoma
- Measurable disease as defined by RECIST criteria
- Unresectable or recurrent thymoma with tumor confined to chest and neck
- Age between 18 and 70 years
- Eastern Cooperative Oncology Group performance status 0 or 1
- No prior chest radiation
- Adequate organ functions
- Written informed consent obtained
You will not qualify if you...
- Contraindications to methylprednisolone
- History of or concurrent malignancy
- Active infection or myocardial infarction within 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Concurrent with radiotherapy period
Participants receive methylprednisolone daily combined with hypofractionated radiotherapy and weekly chemotherapy with albumin-bound paclitaxel and cisplatin.
Weekly visits for chemotherapy and daily medication during radiotherapy
Duration - Up to 2 years
Participants are monitored for treatment response, toxicities, progression-free survival, overall survival, and quality of life.
Visits at 1-2 months, 1 year, and 2 years after treatment
Trial Site Locations
Total: 1 location
1
Sun yat-sen University Cancer Center
Guanzhou, Guangdong, China, 510000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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