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).
Between the ages of 18 and 80.
ECOG general status score of 0-2 .
Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, stage IIIa-IIIc (AJCC/UICC 8th edition). Largest diameter of primary tumor ≥ 4cm before carbon ion radiotherapy.
Medically inoperable, or patient refuses surgery.
Patients with squamous cell carcinoma treated with bevacizumab before radiotherapy.
Patient fails to comply with the treatment protocol.
Complicated with other malignant tumors that have not been controlled.
Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
Jian Chen
Lead sponsor
Shanghai Proton and Heavy Ion Center
Sponsor institution