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Radiation

PULSAR Radiotherapy for Lung Cancer

Phase < 1

Waitlist Available

Led By KENNETH WESTOVER

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years of age

Histologically proven diagnosis of cancer related to the biopsied site

Must not have

Females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive pregnancy test prior to study entry

Prior administration of anti-VEGF therapy within 1 year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to make a specific type of lung tumor treatment safer without making it less effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include localized pain, skin reactions, fatigue, shortness of breath, and inflammation around the area treated due to high-dose radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer diagnosis was confirmed through a biopsy.

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My tumor is between 1.5 and 5 cm in size.

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My tumor is located near the center of my chest.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy- Survivability and response

Secondary study objectives

Change in Tumor Volume

Other study objectives

Dosimetry

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FeasibilityExperimental Treatment1 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.

0 / 8Eligibility criteria met