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

Trial Summary

What is the purpose of this trial?

The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness.

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 data supports the effectiveness of the PULSAR Radiotherapy treatment for lung cancer?

Research shows that similar treatments, like hypofractionated radiation therapy, have been effective in treating lung cancer by delivering high doses of radiation in fewer sessions, which can help control the tumor and improve survival rates. ^{1 2 3 4 5}

Is PULSAR radiotherapy safe for humans?

Research on similar treatments like stereotactic body radiation therapy (SBRT) for lung cancer shows that it has been studied for safety, with some studies focusing on the maximum tolerated dose and adverse effects. This suggests that safety has been a consideration in related treatments. ^{2 4 6 7 8}

How is PULSAR Radiotherapy different from other lung cancer treatments?

PULSAR Radiotherapy is unique because it uses a personalized approach with ultra-fractionated stereotactic ablative radiotherapy, which means it delivers very high doses of radiation in fewer sessions, potentially improving tumor control while minimizing damage to surrounding healthy tissue. ^{2 3 9 10 11}

Research Team

KENNETH WESTOVER, MD, PhD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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.

My tumor is between 1.5 and 5 cm in size.

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 am not planning to receive other local lung treatments while in this study, except if my disease gets worse.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Long-term Outcomes After Moderate Hypofractionated Proton Therapy for Centrally Located Non-small Cell Lung Cancer. [2023]

2. China pubmed.ncbi.nlm.nih.gov

Observation of the short-term therapeutic effect of 3D conformal hypofractionated single high-dose radiotherapy on lung tumors. [2006]

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

Survival and Toxicity of Hypofractionated Intensity Modulated Radiation Therapy in 4 Gy Fractions for Unresectable Stage III Non-Small Cell Lung Cancer. [2021]

4. Ireland 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. [2022]

5. Cyprus pubmed.ncbi.nlm.nih.gov

Toxicity and efficacy of a hypofractionated (3 weekly fractions of 850c Gy) irradiation schedule for stage IIIb / IV non-small cell lung cancer elderly patients with low performance status and unfit for chemotherapy. [2019]

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

Stereotactic body radiation therapy in centrally and superiorly located stage I or isolated recurrent non-small-cell lung cancer. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

Phase I study of stereotactic body radiation therapy for centrally located stage IA non-small cell lung cancer (JROSG10-1). [2018]

8. United States 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. [2022]

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

Stereotactic radiotherapy for nonsmall cell lung cancer. [2018]

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

Combined-modality therapy of locally advanced non-small-cell lung cancer. [2007]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Image-guided hypofractionated small volume radiotherapy of non-small cell lung cancer - feasibility and clinical outcome. [2018]