Stereotactic Radiosurgery for Metastatic Brain Tumors

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Brain TumorsStereotactic Radiosurgery - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if not treating the margins around the tumor during radiation therapy will worsen progression free survival rates in patients with brain metastases.

Eligible Conditions
  • Metastatic Brain Tumors

Treatment Effectiveness

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 6 years

2 years
Association between dose and risk of radionecrosis or pseudoprogression
Local failure rates
Progression free survival (PFS) rates estimated by the Kaplan-Meier method
Rates of distant intracranial failure
Rates of pseudoprogression
Rates of radiation necrosis
Rates of salvage therapy
6 months
Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months
6 years
Overall survival rates
Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities
90 days
Heart rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Stereotactic Radiosurgery Followed by Erlotinib
32%Fatigue
28%Lymphocyte count decreased
24%Cough
20%Back pain
20%Rash acneiform
16%Dry skin
16%Rash maculo-papular
16%Anorexia
16%Hyperglycemia
12%Diarrhea
12%Dyspepsia
12%Pain in extremity
12%Aspartate aminotransferase increased
12%Headache
12%Nausea
12%Pain
12%Non-cardiac chest pain
8%Abdominal pain
8%Blurred vision
8%Edema limbs
8%Watering eyes
8%Paronychia
8%Arthralgia
8%Pruritus
8%Urinary tract pain
8%Skin and subcutaneous tissue disorders - Other, specify
8%Myalgia
8%Weight loss
8%Wheezing
4%Vomiting
4%Urinary tract infection
4%Bruising
4%Infusion site extravasation
4%Dysphagia
4%Conjunctivitis
4%Ear pain
4%Fall
4%Dry eye
4%Fracture
4%Alkaline phosphatase increased
4%Blood bilirubin increased
4%Edema face
4%Bone pain
4%Depression
4%Hyperkalemia
4%Neck pain
4%Oral hemorrhage
4%Platelet count decreased
4%Skin hyperpigmentation
4%Upper respiratory infection
4%Urinary urgency
4%Skin infection
4%Gastroesophageal reflux disease
4%Lethargy
4%Dysgeusia
4%Epistaxis
4%Flu like symptoms
4%Hypernatremia
4%Nail loss
4%Nail ridging
4%Flashing lights
4%Insomnia
4%Hot flashes
4%Neutrophil count decreased
4%Sore throat
4%Papulopustular rash
4%White blood cell decreased
4%Pneumonitis
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT01573702) in the Stereotactic Radiosurgery Followed by Erlotinib ARM group. Side effects include: Fatigue with 32%, Lymphocyte count decreased with 28%, Cough with 24%, Back pain with 20%, Rash acneiform with 20%.

Trial Design

2 Treatment Groups

Stereotactic Radiosurgery to 2 mm GTV to PTV margins
1 of 2
Stereotactic Radiosurgery to 0 mm GTV to PTV margins
1 of 2

Active Control

Experimental Treatment

166 Total Participants · 2 Treatment Groups

Primary Treatment: Stereotactic Radiosurgery · No Placebo Group · Phase 2

Stereotactic Radiosurgery to 0 mm GTV to PTV margins
Procedure
Experimental Group · 1 Intervention: Stereotactic Radiosurgery · Intervention Types: Procedure
Stereotactic Radiosurgery to 2 mm GTV to PTV margins
Procedure
ActiveComparator Group · 1 Intervention: Stereotactic Radiosurgery · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2012
Completed Phase 2
~320

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 years

Who is running the clinical trial?

University of ChicagoLead Sponsor
927 Previous Clinical Trials
753,846 Total Patients Enrolled
Steven J. Chmura, M.D., Ph.D.Principal InvestigatorUniversity of Chicago

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to understand and are willing to sign a written informed consent document.
You are a woman of child-bearing potential.
A well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm