Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma
NCT ID: NCT06730308
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2024-11-20
2028-11-19
Brief Summary
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Detailed Description
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Methylprednisolone will be administered daily during radiotherapy at a dose of 2 mg/kg.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study arm
Methylprednisolone combined with concurrent chemoradiotherapy
Radiotherapy
Hypofractionated radiotherapy
Concurrent chemotherapy
weekly albumin-bound paclitaxel (50 mg/m²) and cisplatin (25 mg/m²)
Methylprednisolone
Methylprednisolone 2mg/kg, qd, concurrent with radiotherapy
Interventions
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Radiotherapy
Hypofractionated radiotherapy
Concurrent chemotherapy
weekly albumin-bound paclitaxel (50 mg/m²) and cisplatin (25 mg/m²)
Methylprednisolone
Methylprednisolone 2mg/kg, qd, concurrent with radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Hui Liu
Professor
Locations
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Sun yat-sen University Cancer Center
Guanzhou, Guangdong, China
Countries
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Facility Contacts
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Bo Qiu
Role: primary
Other Identifiers
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GASTO10106
Identifier Type: -
Identifier Source: org_study_id