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Radiation Therapy

Stereotactic Body Radiotherapy (SBRT) with/without chemotherapy for Metastatic Disease

Phase 2

Waitlist Available

Led By Gregory J Kubicek, MD

Research Sponsored by Steven Burton

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will help researchers learn if a new cancer treatment is effective and safe.

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

Acceptable Toxicity of SRS/SBRT

Presence of Multiple Metastatic Sites

Secondary outcome measures

Analysis of Patterns of Failure Post-SRS/SBRT

Local Control of Metastatic Disease

Local Control of Primary Disease

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stereotactic Body Radiotherapy (SBRT) with/without chemotherapyExperimental Treatment2 Interventions

Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease. Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery (SRS)

2012

Completed Phase 2

~240

Chemotherapy

2003

Completed Phase 4

~3050

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Steven BurtonLead Sponsor

3 Previous Clinical Trials

199 Total Patients Enrolled

Gregory J Kubicek, MDPrincipal InvestigatorUniversity of Pittsburgh

Steve J Burton, MDPrincipal InvestigatorUPMC Hillman Cancer Center

Frequently Asked Questions

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

Has this therapeutic approach been endorsed by the FDA?

"The safety of the treatment has been rated a 2, as this is a phase 2 trial and there are limited data points to suggest its efficacy."

Answered by AI

What is the enrollment capacity for this clinical trial?

"Confirmed. The details published on clinicaltrials.gov verify that this experiment is actively seeking volunteers; it was first posted on June 1st, 2011 and recently reaffirmed in late August of 2020. 44 individuals are necessary to be recruited from 1 medical hub."

Answered by AI

Are there any vacancies yet on this experiment for participants?

"Affirmative. According to the clinicaltrials.gov website, this medical investigation is currently recruiting patients with a start date of June 1st 2011 and most recent update on August 26th 2020. 44 subjects are needed from a single center for successful completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation

Steven Burton 2013. "Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01345539.