A Prospective, Single-arm Phase II Study of Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Sun Yat-sen University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Objective response rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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.
Arms & Interventions
Study arm
Methylprednisolone combined with concurrent chemoradiotherapy
Intervention: Radiotherapy (Radiation)
Study arm
Methylprednisolone combined with concurrent chemoradiotherapy
Intervention: Concurrent chemotherapy (Drug)
Study arm
Methylprednisolone combined with concurrent chemoradiotherapy
Intervention: Methylprednisolone (Drug)
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 1-2 months after chemoradiotherapy
The percentage of patients who achieve complete remission or partial remission after chemoradiotherapy
Secondary Outcomes
- Progression-free survival(2-year)
- Overall survival(2-year)
- Toxicities using the CTCAE 5.0(1 year after treatment)
- Quality of life scores(1 year after treatment)
Investigators
Hui Liu
Professor
Sun Yat-sen University