Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma

NCT06730308 | Recruiting Phase 2

• 1 other identifier: GASTO10106
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thymoma

Keywords

Thymoma; Concurrent chemoradiotherapy; Methylprednisolone

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The percentage of patients who achieve complete remission or partial remission after chemoradiotherapy

  1-2 months after chemoradiotherapy

Secondary Outcomes (4)

• Progression-free survival

  2-year

• Overall survival

  2-year

• Toxicities using the CTCAE 5.0

  1 year after treatment

• Quality of life scores

  1 year after treatment

Study Arms (1)

Study arm

EXPERIMENTAL

Methylprednisolone combined with concurrent chemoradiotherapy

Radiation: Radiotherapy; Drug: Concurrent chemotherapy; Drug: Methylprednisolone

Interventions

Radiotherapy RADIATION

Hypofractionated radiotherapy

Study arm

Concurrent chemotherapy DRUG

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

Study arm

Methylprednisolone DRUG

Methylprednisolone 2mg/kg, qd, concurrent with radiotherapy

Study arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guanzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Thymoma

Interventions

Radiotherapy; Methylprednisolone

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 19, 2028
• Study Completion (Estimated): November 19, 2028
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)