OncoMatch/Clinical Trials/NCT06205927
Randomized Study of Carbon Ion Boost in Hypoxic Lesions for Locally Advanced Non-small Cell Lung Cancer
Is NCT06205927 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for non-small cell lung cancer.
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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage IIIA, IIIB, IIIC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: bevacizumab (bevacizumab)
Patients with squamous cell carcinoma treated with bevacizumab before radiotherapy
Cannot have received: chest radiation therapy
Chest radiation therapy or radioactive particle implantation history
Lab requirements
Blood counts
ANC ≥1.5 x 10^9/L, platelet count ≥80 x 10^9/L, hemoglobin ≥9 g/dL
Kidney function
serum creatinine ≤1.5x ULN or CrCl ≥50 ml/min, urinary protein <2+ (if ≥2+, 24-hour urine protein ≤1g)
Liver function
total bilirubin <1.5x ULN, AST/ALT <2x ULN
Cardiac function
no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy
Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1>25%, DLCO>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin <1.5 times the upper limit of normal value, and AST, ALT<2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml /min, and urinary protein <2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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