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Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma

NCT06924619 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2025-04-24

No results posted yet for this study

Summary

The goal of this prospective, randomized, controlled phase II clinical study is to evaluate the efficacy and safety of neoadjuvant radiotherapy in patients with locally advanced unresectable thymoma. The main questions it aims to answer are:

1. Which treatment method is more effective in improving the radical resection rate: neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy ?
2. The safety and adverse reactions of neoadjuvant radiotherapy? Does the addition of neoadjuvant chemotherapy have an impact on this?

Participants will be randomly divided into two groups: one group will receive neoadjuvant radiotherapy, and the other will receive neoadjuvant chemoradiotherapy. The primary endpoint of the study is to evaluate the radical resection rate (R0) of two groups. The secondary endpoints will include the pathological complete response rate (pCR), 3-year progression-free survival, and safety and toxicities. In addition, this study will explore the feasibility and completion rate of minimally invasive surgical resection.

Conditions

  • Locally Advanced Thymoma

Interventions

RADIATION

neoadjuvant radiotherapy

Target the primary tumor region with 40-50 Gy in 20-25 fractions.

DRUG

cisplatin

The cisplatin will be given concurrently with radiotherapy (25 mg/m² , D1, QW) for 4-5 cycles.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2026-05-01
Completion
2029-05-01

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06924619 on ClinicalTrials.gov