Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma

Sun Yat-sen University

Status and phase

Enrolling

Phase 2

Conditions

Thymoma

Treatments

Radiation: Radiotherapy

Drug: Methylprednisolone

Drug: Concurrent chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06730308

GASTO10106

Details and patient eligibility

About

This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.