200 Participants NeededMy employer runs this trial

Hotspot vs Traditional Radiotherapy for Lung Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial compares stereotactic ablative radiotherapy (SBRT) with hot spots to standard of care SBRT for the treatment of patients with early-stage non-small cell lung cancer. SBRT with hot spots intentionally makes sure the tumor gets a higher radiation dose during treatment. This potentially may result in better control of the tumor, but also more side effects. SBRT with or without hot spots may be more effective in treating patients with early-stage non-small cell lung cancer, compared to standard of care SBRT.

Who Is on the Research Team?

MF

Mark Farrugia

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults (18+) with early-stage non-small cell lung cancer who are healthy enough for focused radiation therapy. Participants must not have certain immune or lung conditions, recent overlapping chest radiation, or be pregnant/nursing. They need to use birth control and agree to study procedures.

Inclusion Criteria

Participant must understand the investigational nature of the study and sign approved informed consent prior to any study procedure
I am eligible to receive SABR (stereotactic body radiation therapy).
Participants of child-bearing potential must agree to use adequate contraceptive methods prior to study entry and inform physician if pregnancy occurs or is suspected
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Exclusion Criteria

I have needed treatment for an active autoimmune disease in the past 2 years.
I have had radiation to my chest that could affect this treatment.
I have not had lung cancer treatment in the past 6 months.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive either standard of care SBRT or hot spot SBRT for 1-5 fractions over 1-11 days

1-2 weeks
1-5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months
Every 3 months for 1 year, then every 3-6 months up to month 36

What Are the Treatments Tested in This Trial?

Interventions

  • Stereotactic Body Radiation Therapy (SBRT) with Hot Spots

Trial Overview

The study compares two types of focused radiation: standard SBRT versus SBRT that targets the tumor with extra-high doses ('hot spots'). The goal is to see if the higher dose improves tumor control in early-stage non-small cell lung cancer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm I (SOC SBRT)Experimental Treatment6 Interventions
Group II: Aim II (hot spot SBRT)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+