PVB-SABR for Lung Cancer

Overseen By Anoushka Kathiravan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Severe pulmonary fibrosis, Pneumothorax, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to evaluate and determine the rate of successful administration of Percussive ventilation breathhold (PVB) to allow for more accurate radiotherapy for lung tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment PVB-SABR for lung cancer?

Research shows that Stereotactic Ablative Radiotherapy (SABR) is effective in controlling tumors and improving survival in patients with non-small cell lung cancer (NSCLC) and pulmonary metastases. SABR is a precise radiation treatment that delivers high doses over a few sessions, making it a standard care option for early-stage lung cancers that cannot be surgically removed. ^{1 2 3 4 5}

How is the PVB-SABR treatment for lung cancer different from other treatments?

PVB-SABR (Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy) is unique because it combines high-precision radiation therapy with a technique that helps patients hold their breath during treatment, allowing for more accurate targeting of lung tumors. This approach is particularly beneficial for patients who cannot undergo surgery, offering a non-invasive alternative with comparable outcomes to surgical resection. ^{1 3 4 5 6}

Research Team

Wilson X Mai, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults with primary lung cancer or lung metastases who are fit enough for standard radiotherapy. It's open to those with a performance status of up to 3 if doctors think it's safe. Pregnant women, patients with very large tumors, severe pulmonary fibrosis, recent pneumothorax, or critical illnesses like active infections can't participate.

Inclusion Criteria

I have been diagnosed with lung cancer or cancer that has spread to my lungs.

I can do some activities but not work, or I'm mostly in bed but can be up.

I am considered fit for standard lung cancer radiation treatment.

Exclusion Criteria

No Pregnant Women

I have recently developed a collapsed lung.

I am not a candidate for standard lung SABR due to my condition or tumor size.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB-SABR) for lung cancer treatment

18 months

Regular visits for treatment and monitoring

Exploratory Data Collection

Collection of optional exploratory clinical and dosimetric data during PVB

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Percussive Ventilation Breathhold SABR (PVB-SABR)

Trial Overview The study is testing PVB-SABR—a technique using percussive ventilation during breathholds—to improve the precision of stereotactic ablative radiotherapy for treating lung tumors. The goal is to see how well patients can receive this treatment.

Participant Groups

Group I: Administration of the PVB-SABR in lung cancer patients Experimental Treatment 1 Intervention

Lung cancer patients will execute a PV breathhold and a verification cone-beam CT scan.

Group II: Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers Experimental Treatment 1 Intervention

The healthy patient will execute the Percussive ventilation breathhold technique

Percussive Ventilation Breathhold SABR (PVB-SABR) is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as SABR for:

• Primary lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Brain metastases

Approved in United States as SABR for:

• Primary lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Brain metastases

Approved in United Kingdom as SABR for:

• Primary lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Brain metastases

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

Stereotactic ablative body radiotherapy (SABR) is a significant advancement in radiotherapy that has been shown to improve tumor control and overall survival in patients with lung tumors.

The review highlights the current evidence supporting the efficacy of SABR for both primary and secondary lung tumors, along with ongoing trials that may further validate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. Goldsmith, C., Gaya, A.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Stereotactic ablative radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).

Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]

In a multicenter phase 3 trial involving 101 patients with inoperable stage 1 non-small-cell lung cancer, stereotactic ablative body radiotherapy (SABR) demonstrated significantly better local control compared to standard radiotherapy, with a 68% reduction in the risk of local treatment failure (hazard ratio 0.32).

SABR was associated with a similar safety profile to standard radiotherapy, showing no increase in major toxicity, making it a preferred treatment option for patients with this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Ball, D., Mai, GT., Vinod, S., et al.[2022]

Stereotactic ablative body radiotherapy (SABR) is now the standard treatment for early-stage non-small-cell lung cancer (NSCLC) in patients who cannot undergo surgery, highlighting its efficacy in this patient population.

The review also discusses the safety profile of SABR, including reported toxicity rates, and explores its potential use in combination with other therapies for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. Murray, P., Franks, K., Hanna, GG.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. [2022]