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Radiation Therapy

SBRT + Standard of Care for Metastatic Breast Cancer

Phase 2

Recruiting

Led By T. Jonathan Yang, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

ECOG Performance status 0 - 2

Age >/= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing if SBRT can help people with 1-5 metastases live longer before their disease gets worse.

Who is the study for?

This trial is for adults with certain types of breast or non-small cell lung cancer that has spread (1-5 metastases). They should be able to undergo SBRT, have a performance status of 0-2, and not be pregnant. Excluded are those with serious health issues preventing radiotherapy, spinal cord compression signs, malignant effusions, another active cancer in the last year.Check my eligibility

What is being tested?

The study tests if adding Stereotactic Body Radiotherapy (SBRT) to standard systemic therapy prolongs the time before worsening of metastatic breast or non-small cell lung cancer. It targets patients with limited sites of disease amenable to this precise radiation technique.See study design

What are the potential side effects?

Potential side effects include skin reactions at the treatment site, fatigue, nausea, and inflammation around organs close to where SBRT is delivered. There may also be risks associated with radiation exposure such as damage to nearby tissues or organs.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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My NSCLC progressed after first-line treatment with a tyrosine kinase inhibitor.

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My cancer has spread to other parts and this was confirmed by tests.

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My breast cancer is triple negative or ER+ and I'm receiving chemotherapy.

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My lung cancer does not have changes in EGFR, ALK, or ROS1 genes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Progression Free Survival

Secondary outcome measures

Overall Survival

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stereotactic Body Radiotherapy (SBRT) + Standard of CareExperimental Treatment2 Interventions

Patients enrolled on Arm 2 of the study will undergo Stereotactic Body Radiotherapy/SBRT to all known metastases seen on imaging studies performed prior to enrollment. Radiotherapy will be given concurrently to all metastatic sites. Minimum BED for ablative SBRT is more than or equal to 48 Gy10. Patients can undergo systemic therapy concurrently with SBRT at the discretion of treating radiation oncologist and medical oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.

Group II: Standare of CareActive Control1 Intervention

Patients with newly diagnosed metastatic non-small cell lung cancer or triple negative breast cancer may be enrolled on protocol prior to receiving any systemic therapy. If these patients are randomized to the standard of care arm (Arm 1), they will initiate appropriate therapy as determined by their oncologist. Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,753 Total Patients Enrolled

T. Jonathan Yang, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

147 Total Patients Enrolled

Divya Yerramilli, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

102 Total Patients Enrolled

Media Library

Stereotactic Body Radiotherapy/SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03808337 — Phase 2

Non-Small Cell Lung Cancer Clinical Trial 2023: Stereotactic Body Radiotherapy/SBRT Highlights & Side Effects. Trial Name: NCT03808337 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Stereotactic Body Radiotherapy (SBRT) + Standard of Care, Standare of Care

Stereotactic Body Radiotherapy/SBRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808337 — Phase 2

Frequently Asked Questions

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

How many test subjects are included in this research?

"That is correct, the listing on clinicaltrials.gov does show that 145 patients are needed for the study between 13 different sites. The trial was first posted on 1/16/2019 and has had 8/24/2022 as its most recent update."

Answered by AI

Are there any current openings for people who wish to participate in this research?

"The study is still recruiting participants, as seen on clinicaltrials.gov. This information was originally posted on 1/16/2019, with the most recent update being 8/24/2022."

Answered by AI

Could you please list how many facilities are participating in this clinical trial?

"There are a total of 13 sites where this study is taking place, which are located in Commack, Uniondale, New york and 10 other places. If you decide to participate in this trial, try to select the site that is closest to your home to limit travel."

Answered by AI