Hypervision proton surgery for early-stage non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, single-arm study used a dose-escalation, two-stage two-dose-group design to test single large fraction proton radiation delivered as either 34 GyE or 39 GyE for early peripheral NSCLC. Eligible tumors were T1 (≤3 cm) N0M0 located at least 2 cm from the proximal bronchial tree, and participants needed good performance status and adequate lung function. The primary focus was on safety and tolerability of the high single-fraction doses, with secondary attention to local control and short-term efficacy. Treatments were delivered at Anhui Provincial Hospital with pre-treatment imaging and multidisciplinary review guiding eligibility.

Why it matters

Who can join: the full rules

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)

Where it's running

• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting

Study contacts

• Principal investigator: Shuanghu Yuan, PhD — Anhui Provincial Hospital
• Study coordinator: Shuanghu Yuan, PhD
• Email: yuanshuanghu@sina.com
• Phone: 0551-62894008

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.