Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma

December 11, 2024 updated by: Hui Liu, Sun Yat-sen University

A Prospective, Single-arm Phase II Study of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China, 510000
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study arm
Methylprednisolone combined with concurrent chemoradiotherapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 1-2 months after chemoradiotherapy
The percentage of patients who achieve complete remission or partial remission after chemoradiotherapy
1-2 months after chemoradiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2-year
From the start date of initial treatment to death or to last follow-up.
2-year
Progression-free survival
Time Frame: 2-year
From the start date of initial treatment to progression, death or last follow-up
2-year
Toxicities using the CTCAE 5.0
Time Frame: 1 year after treatment
Toxicities were evaluated using the CTCAE 5.0
1 year after treatment
Quality of life scores
Time Frame: 1 year after treatment
Quality of life assessed by QLQ-C30
1 year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Estimated)

November 19, 2028

Study Completion (Estimated)

November 19, 2028

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Estimated)

December 12, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO10106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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