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Radiation Therapy

SBRT for Non-Small Cell Lung Cancer

N/A
Waitlist Available
Led By Anurag Singh, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is considered to be either medically or surgically inoperable by physicians, or participant declines surgery.
Have an ECOG Performance Status of ≤ 2. Refer to Appendix A.
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the safety and effectiveness of one high dose of targeted radiation (SBRT) to multiple lower doses in patients with central non-small cell lung cancer.

Who is the study for?
This trial is for adults with a confirmed diagnosis of central non-small cell lung cancer (NSCLC) that's in an early stage and smaller than 6 cm. They should be unable to have or refuse surgery, not pregnant, and haven't had recent chemotherapy or radiation. Participants must understand the study's experimental nature and agree to use birth control if they can have children.
What is being tested?
The study tests whether one session of targeted radiation therapy (SBRT) is as effective and safe as multiple sessions for treating central NSCLC. It aims to see if this single treatment can help patients who are not candidates for surgery.
What are the potential side effects?
Potential side effects from SBRT may include skin reactions at the site of treatment, fatigue, shortness of breath, chest pain, coughing up blood, difficulty swallowing due to inflammation near treated areas like esophagus or lungs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot or choose not to have surgery for my condition.
Select...
I am able to get out of my bed or chair and move around.
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My tumor is not near critical chest areas as defined by lung cancer experts.
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My cancer is localized and the tumor is smaller than 6 cm.
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My lung cancer is confirmed to be non-small cell type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I do not have brain metastases.
Select...
I cannot undergo SBRT due to an inability to stay still or other reasons.
Select...
I have had radiation therapy on the lung or chest area affected by cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Rate of grade 3-5 adverse events
Secondary study objectives
Local Control Rate
Overall Survival
Progression-free Survival
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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: Stereotactic Body Radiation Therapy (SBRT)Experimental Treatment1 Intervention
A single fraction of targeted SBRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
412 Previous Clinical Trials
32,705 Total Patients Enrolled
Anurag Singh, MDPrincipal InvestigatorRoswell Park Comprehensive Cancer Center
2 Previous Clinical Trials
906 Total Patients Enrolled

Media Library

SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05138900 — N/A
~16 spots leftby Mar 2028
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