Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201513, China
Location status: Recruiting
NCT Number: NCT06205927
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).
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 201513, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months
Local progression-free survival was defined from the start of carbon ion radiotherapy till the date of local progression or the last follow-up
Time frame: From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up
Time frame: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months
Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up
Time frame: From date of radiotherapy started until 6 months after first radiotherapy
Proportion of complete response and partial response in all patients
Time frame: From date of radiotherapy started until 1 month after first radiotherapy
The hypoxia volume of the hypoxia-positive region of interested was defined as the sum of pixels with a tumor muscle rate ≥1.4. The FHV, defined as the HV-to-gross tumour volume ratio. The FHV before and after carbon ion radiotherapy within 1 month will be recorded.
Time frame: From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months
Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and EORTC/RTOG criteria, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.
Interested in participating?
Request InfoJian Chen
Other
Randomized Study of Carbon Ion Boost in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients With Non-Small Cell Lung Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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