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Randomized Study of Carbon Ion Boost in Hypoxic Lesions for Locally Advanced Non-small Cell Lung Cancer
Sponsor: Jian Chen
Summary
The goal of this randomized clinical trial is to learn about if carbon ion radiotherapy dose boost in hypoxia lesions detected by 18F-Misonidazole PET/CT could improve clinical outcomes in locally advanced non-small cell lung cancer patients compared with standard treatment protocol in our center. The patients will be randomly divided into two arms: standard treatment arm and hypoxic lesions dose boost arm. The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume. The hypoxic lesions dose boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT. Researchers will compare the local progression-free survival of two groups (primary endpoint), progression-free survival (secondary endpoint), overall survival (secondary endpoint), response rate (secondary endpoint), factional hypoxia volume (FHV) reduction rate (secondary endpoint) and toxicities (secondary endpoint).
Official title: Randomized Study of Carbon Ion Boost in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients With Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
77
Start Date
2023-12-07
Completion Date
2026-12-31
Last Updated
2025-06-17
Healthy Volunteers
No
Conditions
Interventions
Standard carbon ion beam radiotherapy
The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume.
Carbon ion beam radiotherapy simultaneously dose boost
The hypoxic lesions dose boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT.
Locations (1)
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China