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NCT Number: NCT06730308

Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun yat-sen University Cancer Center

Guanzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy

Radiation

Hypofractionated radiotherapy

Concurrent chemotherapy

Drug

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

methylprednisolone

Drug

Methylprednisolone 2mg/kg, qd, concurrent with radiotherapy

Primary outcomes

  1. 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

  1. Progression-free survival

    Time frame: 2-year

    From the start date of initial treatment to progression, death or last follow-up

  2. Overall survival

    Time frame: 2-year

    From the start date of initial treatment to death or to last follow-up.

  3. Toxicities using the CTCAE 5.0

    Time frame: 1 year after treatment

    Toxicities were evaluated using the CTCAE 5.0

  4. Quality of life scores

    Time frame: 1 year after treatment

    Quality of life assessed by QLQ-C30

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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