To Explore the Safety and Efficacy of Hypervision Proton Surgery for Early-stage Non-small Cell Lung Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Cancer Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Hypervision proton surgery

    Radiation

    Proton radiaotherapy (34GyE or 39GyE)

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Proton radiotherpyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of grade ≥ 3 psAEs at 1 month

Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)

Time frame
1 month after proton radiotherapy
2

The incidence of grade ≥ 3 psAEs at 1 year

Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)

Time frame
1 year after proton radiotherapy

Secondary outcomes

1

Primary tumor control at 1 year

Primary tumor control at 1 year

Time frame
1 year after proton radiotherapy
2

Disease-free survival time

Disease-free survival time

Time frame
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
3

Overall survival time

Overall survival time

Time frame
From date of treatment until the date of death

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Cancer Hospital

Lead sponsor

Anhui Provincial Hospital

Sponsor institution

Anhui Provincial Hospital

Collaborator