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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of grade 3-5 adverse events

Secondary outcome measures

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

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,828 Total Patients Enrolled

Anurag Singh, MDPrincipal InvestigatorRoswell Park Comprehensive Cancer Center

1 Previous Clinical Trials

106 Total Patients Enrolled

Media Library

SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05138900 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to contribute to this research endeavor?

"As displayed on clinicaltrials.gov, this investigation is open to fresh enrollees; it was initially advertised in December 2021 and has been revised most recently in September 2022."

Answered by AI

What is the current size of the cohort involved in this research study?

"Affirmative. As indicated on clinicaltrials.gov, this study is actively seeking enrolment from participants; it was first posted in December 16th 2021 and has since been updated on September 27th 2022. 30 volunteers are required for the trial at a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pilot Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) in Central Non-Small Cell Lung Cancer

2021. "A Pilot Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) in Central Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05138900.