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 trial explores two types of radiation therapy for individuals with early-stage non-small cell lung cancer. It compares standard radiation treatment to a new method that targets the tumor with extra-high doses, known as "hot spots" (Stereotactic Body Radiation Therapy, or SBRT, with Hot Spots). The researchers aim to determine if this new method better controls the cancer, though it might also cause more side effects. Individuals diagnosed with early-stage non-small cell lung cancer who haven't received radiation to the chest area in the past six months might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that stereotactic body radiation therapy (SBRT) with hot spots can cause more side effects, particularly for tumors located in the center of the lung. Patients might experience more side effects compared to other treatments. However, SBRT is designed to deliver higher doses of radiation directly to the tumor, potentially improving control.

Past studies have demonstrated SBRT's effectiveness in controlling cancer in the treated area. For instance, one study found it controlled cancer in 92% of patients. Despite the risk of side effects, many patients tolerate the treatment well, achieving good results in managing early-stage non-small cell lung cancer.

Balancing the potential for better tumor control against the risk of increased side effects is crucial. Consulting healthcare providers can help determine if this treatment is suitable.12345

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about using Hotspot Stereotactic Body Radiation Therapy (SBRT) for lung cancer because it targets the tumor with higher radiation doses in fewer sessions. Unlike traditional SBRT, this approach potentially maximizes tumor control while minimizing exposure to surrounding healthy tissues, reducing side effects. Most lung cancer treatments involve continuous radiation over several weeks, but Hotspot SBRT can deliver effective results in just 1-5 sessions over 1-11 days, offering a quicker and potentially more effective alternative.

What evidence suggests that this trial's treatments could be effective for early-stage non-small cell lung cancer?

This trial will compare two approaches to stereotactic body radiation therapy (SBRT) for lung cancer: hot spot SBRT and standard-of-care (SOC) SBRT. Research has shown that stereotactic ablative body radiotherapy (SABR), similar to SBRT, holds promise for treating early-stage non-small cell lung cancer (NSCLC). SABR uses focused radiation to precisely target tumors, helping to control their growth. Studies have found that SABR can offer results similar to surgery for patients unable to undergo an operation. Additionally, SABR can deliver a higher dose of radiation directly to the tumor, potentially improving its effectiveness. However, this could also increase side effects. While SABR has proven effective, researchers continue to study the use of higher doses to understand its benefits and risks.678910

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
See 4 more

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+

Citations

Stereotactic surgery

A 2021 systematic review from the Agency for Healthcare Research and Quality found no statistically significant difference in overall survival for stereotactic ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/42144018/

Long-term outcomes of stereotactic ablative body ...

Long-term outcomes of stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a multicentre, non-randomised, phase 2 study.

Stereotactic radiosurgery

Stereotactic radiosurgery (SRS) uses many precisely focused radiation beams to treat tumors and other problems in the brain, neck, lungs, ...

4.

karger.com

karger.com/sfn

Stereotactic and Functional Neurosurgery

Stereotactic and Functional Neurosurgery is the single and comprehensive source of developments in the most rapidly advancing subspecialty within neurosurgery.

Mammography Guided Breast Biopsy - Roswell Park

If you are having a stereotactic or mammography guided breast biopsy, this video aims to answer some common questions about the procedure.

Long-term Clinical Outcomes and Safety Profile of SBRT for ...

Previous studies suggest that stereotactic body radiation therapy (SBRT) is associated with higher toxicity rates for central lung tumors relative to peripheral ...

STEREOTACTIC BODY RADIATION THERAPY FOR ... - PMC

SBRT provided in-field local control for 92% of patients; at 2 years, the actuarial overall survival rate was 59%, and the actuarial progression-free survival ...

Hotspot Stereotactic Ablative Radiotherapy Versus ...

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 ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37574234/

Some Like It Hot: The Value of Dose and Hot Spots in Lung ...

Some Like It Hot: The Value of Dose and Hot Spots in Lung Stereotactic Body Radiation Therapy.

Hotspot vs Traditional Radiotherapy for 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 ...