Non-Small Cell Lung Cancer
Conditions
Keywords
non-small cell lung cancer; Hypervision proton surgery
Brief summary
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.
Detailed description
This study adopted a dose escalation protocol (an improved "two-stage two-dose group" design) to explore the safety and efficacy of visual proton surgery (single large fractionated doses of 34GyE and 39GyE) in the treatment of early peripheral NSCLC.
Interventions
RADIATIONHypervision proton surgery
Proton radiaotherapy (34GyE or 39GyE)
Sponsors
Anhui Provincial Cancer Hospital
Anhui Provincial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * The tumor must be more than 2 cm away from the proximal bronchial tree in all directions (the proximal bronchial tree is defined as 2 cm from the distal end of the trachea, the protrusion and the named lobar bronchus up to its first bifurcation) * FEV1 ≥ 1 L, FEV1 ≥ 40% of the predicted value (either one is sufficient); DLCO ≥ 40% of the predicted value * The patient can tolerate PET-CT examination * For female study participants of childbearing age, the urine or serum pregnancy test was negative within 7 days prior to the first administration of the study drug. If the result of the urine pregnancy test is positive, a blood pregnancy test is required
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade ≥ 3 psAEs at 1 month | 1 month after proton radiotherapy | Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) |
| The incidence of grade ≥ 3 psAEs at 1 year | 1 year after proton radiotherapy | Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary tumor control at 1 year | 1 year after proton radiotherapy | Primary tumor control at 1 year |
| Disease-free survival time | From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Disease-free survival time |
| Overall survival time | From date of treatment until the date of death | Overall survival time |
Countries
China
Contacts
CONTACTShuanghu Yuan, PhD
CONTACTLi Li, PhD
PRINCIPAL_INVESTIGATORShuanghu Yuan, PhD
Anhui Provincial Hospital
Outcome results
None listed