RecruitingPhase 2NCT06730308

Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma

A Prospective, Single-arm Phase II Study of Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma


Sponsor

Sun Yat-sen University

Enrollment

45 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

  • 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 Criteria9

  • 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.

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Interventions

RADIATIONRadiotherapy

Hypofractionated radiotherapy

DRUGConcurrent chemotherapy

weekly albumin-bound paclitaxel (50 mg/m²) and cisplatin (25 mg/m²)

DRUGMethylprednisolone

Methylprednisolone 2mg/kg, qd, concurrent with radiotherapy


Locations(1)

Sun yat-sen University Cancer Center

Guanzhou, Guangdong, China

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NCT06730308


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