PULSAR Radiotherapy for Lung Cancer

Overseen By KENNETH WESTOVER, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Anti-VEGF therapy

Disqualifiers: Prior radiotherapy, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2-5 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy, called PULSAR (Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy), to treat lung cancer tumors located very close to vital organs. The goal is to determine if this approach can make the treatment safer without losing effectiveness. It targets individuals with a lung tumor between 1.5 and 5 centimeters, situated near the center of the chest, such as close to the esophagus or bronchial tubes. Those who have had lung cancer and fit this tumor profile may be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how this new treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that PULSAR Radiotherapy is safe for lung cancer patients?

Research has shown that Stereotactic Ablative Radiotherapy (SAbR) can effectively treat lung cancer, even when tumors are near vital organs. Studies have found that SAbR works well at certain doses but may carry some risks. There is a higher chance of side effects, particularly when tumors are in central or very central parts of the lung.

The PULSAR approach aims to enhance safety by customizing the treatment delivery. Although this study is in its early stages, the goal is to maintain treatment effectiveness while improving safety. As an early-phase study, researchers are still assessing patient tolerance to the treatment. Safety is under close observation, and any serious side effects could lead to discontinuation. So far, data suggests that while SAbR shows promise, further work is needed to ensure safety for patients with very central lung cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PULSAR Radiotherapy for lung cancer because it offers a more personalized approach compared to traditional treatments like conventional radiotherapy and chemotherapy. Unlike standard radiotherapy that typically involves continuous daily sessions, PULSAR delivers ultra-fractionated doses with 3-4 weeks between each session, allowing the body more time to recover and potentially reducing side effects. This method also allows for treatment adjustments based on patient response, offering the flexibility to withhold or terminate treatment if a complete response is achieved or if severe side effects occur. This tailored approach could lead to more effective and less taxing cancer treatment experiences.

What evidence suggests that PULSAR Radiotherapy is effective for lung cancer?

Research has shown that Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR), which participants in this trial will receive, holds promise for treating lung cancer. In a study involving 217 patients with lung tumors, PULSAR proved very effective, with many patients experiencing no cancer recurrence in the treated area one year after treatment. This method targets tumors precisely, potentially protecting nearby healthy tissue. PULSAR administers fewer but larger doses of radiation over a longer period, which might make it safer and more effective than traditional daily radiation treatments. Early results suggest that PULSAR could be a strong option for managing lung cancer, although further research is needed to confirm these benefits. ^{1 4 6 7 8}

Who Is on the Research Team?

KENNETH WESTOVER, MD, PhD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with lung cancer, specifically those with tumors located centrally in the lungs. Participants should be suitable candidates for a type of targeted radiation therapy.

Inclusion Criteria

Ability to tolerate MRI

I have been active and mostly self-sufficient in the last 30 days.

All men, as well as women of child-bearing potential, must agree to use adequate contraception from the time of consent, for the duration of study participation, and for 90 days following completion of therapy

Exclusion Criteria

I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.

I have not had anti-VEGF therapy in the last year.

I have had radiation in the same area where my current cancer is located.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PULSAR treatment with 5 fractions, one every 3 weeks, over a total duration of 2-5 months

2-5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR)

Trial Overview The study is testing PULSAR, an advanced form of precise and intense radiation therapy aimed at improving safety and maintaining effectiveness against central lung tumors.

How Is the Trial Designed?

Group I: Feasibility Experimental Treatment 1 Intervention

Patients treated with PULSAR will undergo treatment over a total duration of 2-5 months with 3-4 weeks between each fraction. PULSAR treatments completed within 6 months will be acceptable if treatment breaks are required. In the event of a complete response between fractions, remaining fractions will be withheld at the discretion of the treating physician. Treatment may also be terminated for selected grade 3 or higher AEs. Treatment may also be terminated for regional or systemic progression detected during the PULSAR treatment interval.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Elekta Limited

Industry Sponsor

Trials

13

Recruited

8,900+

Published Research Related to This Trial

Dynamic tumor tracking-stereotactic body radiotherapy (DTT-SBRT) demonstrated a high local control rate of 95.2% for lung tumors after 2 years, indicating its efficacy in managing lung cancer.

The treatment was associated with low severe toxicity, with only 2.1% of patients experiencing grade 3 radiation pneumonitis, and no grade 4 or 5 toxicities reported, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional phase II study on the safety and efficacy of dynamic tumor tracking-stereotactic body radiotherapy for lung tumors. Matsuo, Y., Hiraoka, M., Karasawa, K., et al.[2022]

Fractionated stereotactic radiation therapy (FSRT) based on biological effective dose (BED) demonstrated a high local control rate of 96.3% at 6 months and 94.5% at 12 months for brain metastases from non-small cell lung cancer (NSCLC), indicating its efficacy in managing these tumors.

The treatment showed acceptable toxicity, with only 2% of patients experiencing progressive radiation injury, which improved with hyperbaric oxygen therapy, suggesting that FSRT is a promising option for patients with brain metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of biological effective dose-based fractionated stereotactic radiation therapy for metastatic brain tumors from non-small cell lung cancer. Matsuyama, T., Kogo, K., Oya, N.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06712745

Feasibility Study of Personalized Ultra-fractionated ... ... Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung. Conditions. Cancer, LungMetastasis. Cancer, LungMetastasis.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39727685/

Personalized Ultra-Fractionated Stereotactic Adaptive ... We present a patient treated with personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) for non-small cell lung cancer (NSCLC)

3. utswmed.org utswmed.org/cancer/cancer-answers/pulsar-paradigm-for-effective-radiotherapy/

PULSAR: A Paradigm for Safer, More Effective ... A new approach to radiation therapy that abandons classic daily fractions is now being investigated in rectal, brain, and lung cancer ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301624036411

International Journal of Radiation Oncology*Biology*Physics Exploratory Evaluation of Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) With Central Nervous System-Active Drugs in Brain ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2809582

Individualized Stereotactic Ablative Radiotherapy for Lung ... Findings In this nonrandomized controlled trial of 217 unique patients with 285 treated tumors, rates of freedom from local recurrence at 1 year ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9118536/

Safety and Efficacy of Stereotactic Ablative Radiotherapy for ... Patients with ultra-central lung cancer can benefit from stereotactic body radiotherapy with a dose of 56/6-8f Gy. Smaller PTV was associated ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/560436

Feasibility Study of Personalized Ultra-fractionated ... Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung. First Posted. Dec 2, 2024.

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89742-0/fulltext

Ten years outcomes after SABR in central and ultracentral ... SABR performed for central and ultracentral lung tumors is associated with increased toxicity but limited data is available on late toxicities.