About this trial
This study was a single-center, single-arm clinical study to evaluate the safety and efficacy of hypervision proton surgery with single large fractionated doses (34GyE and 39GyE) in the treatment of early peripheral NSCLC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must be at least 18 years old
Karnofsky Performance Status > 80
NSCLC confirmed by cytology or histology; for subjects who cannot safely obtain pathological evidence due to factors such as tumor lesion location, patient's underlying diseases, or high puncture risk, after unanimous consent of the multidisciplinary team (MDT) discussion, they meet the clinical diagnostic criteria for NSCLC based on typical imaging features (such as enhanced chest CT and/or PET/CT) combined with clinical manifestations;
Early-stage tumors are defined as T1 (≤3cm) N0M0 based on enhanced computed tomography (CT) and positron emission tomography (PET)
Disqualifiers
Other malignant tumors occurred concurrently within 2 years before enrollment
A history of chest radiotherapy in the past
It is planned to use other anti-tumor treatments within the regimen treatment (within 4 weeks)
Trial design
Single group
Treatments tested in this trial
Hypervision proton surgery
RadiationProton radiaotherapy (34GyE or 39GyE)
Treatment groups
Trial outcomes
Primary outcomes
The incidence of grade ≥ 3 psAEs at 1 month
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
The incidence of grade ≥ 3 psAEs at 1 year
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
Secondary outcomes
Primary tumor control at 1 year
Primary tumor control at 1 year
Disease-free survival time
Disease-free survival time
Overall survival time
Overall survival time
Sponsors and contacts
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Anhui Provincial Cancer Hospital
Lead sponsor
Anhui Provincial Hospital
Sponsor institution
Anhui Provincial Hospital
Collaborator