PULSAR Radiotherapy for Lung Cancer
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.12345Why 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.14678
Who Is on the Research Team?
KENNETH WESTOVER, MD, PhD
Principal Investigator
University of Texas 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PULSAR treatment with 5 fractions, one every 3 weeks, over a total duration of 2-5 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Elekta Limited
Industry Sponsor
Published Research Related to This Trial
Citations
Feasibility Study of Personalized Ultra-fractionated ...
... Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung. Conditions. Cancer, LungMetastasis. Cancer, LungMetastasis.
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)
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 ...
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 ...
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 ...
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 ...
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.
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.
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