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Recruiting NCT06730308

Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma

Phase II Interventional Thymoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy, Concurrent chemotherapy, Methylprednisolone.
Who it may be relevant to
Registry conditions: Thymoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation Radiotherapy
    Hypofractionated radiotherapy
  • Drug Concurrent chemotherapy
    weekly albumin-bound paclitaxel (50 mg/m²) and cisplatin (25 mg/m²)
  • Drug Methylprednisolone
    Methylprednisolone 2mg/kg, qd, concurrent with radiotherapy

Primary outcome measures

  • Objective response rate [Time frame: 1-2 months after chemoradiotherapy]
Secondary outcome measures (4)
  • Progression-free survival [Time frame: 2-year]
  • Overall survival [Time frame: 2-year]
  • Toxicities using the CTCAE 5.0 [Time frame: 1 year after treatment]
  • Quality of life scores [Time frame: 1 year after treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun yat-sen University Cancer Center — Guanzhou

Identifiers

NCT: NCT06730308 · GASTO10106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗