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RECRUITING
NCT06924619
PHASE2

Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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.

Official title: A Prospective, Randomized, Controlled Phase Ⅱ Clinical Trial of Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2024-10-30

Completion Date

2029-05-01

Last Updated

2025-04-24

Healthy Volunteers

No

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.

Locations (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China