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Radiation Therapy

Radiosurgery vs Whole Brain Radiation for Brain Metastasis

Phase 3
Waitlist Available
Led By Jing Li
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients must have histological proof of malignant cancer, which is metastatic. Histological proof may be obtained from the primary tumor or another metastatic site. However, cytology alone is not an acceptable method of diagnosis
All patients must be >/= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial compares stereotactic radiosurgery with whole brain radiation therapy to see how well they work in treating patients with non-melanoma cancer that has recently spread from the first location to the brain.

Who is the study for?
This trial is for adults with non-melanoma cancer that has spread to the brain, with 3-15 detectable lesions on MRI. Participants must have proof of malignant cancer and be able to undergo all treatments proposed. They should not have had prior brain surgery or whole-brain radiation, no melanoma or certain other cancers, and women of childbearing age must not be pregnant.Check my eligibility
What is being tested?
The study compares stereotactic radiosurgery (SRS), which targets tumors directly in a single high dose, against whole-brain radiotherapy (WBRT) that treats the entire brain over multiple sessions. The goal is to determine which method is more effective for treating brain metastases from non-melanoma cancers and causes fewer cognitive side effects.See study design
What are the potential side effects?
Potential side effects include damage to normal tissue surrounding the tumor, cognitive and memory problems especially associated with WBRT, fatigue, headaches, hair loss from radiation exposure, skin irritation at treatment sites, and possible short-term swelling within the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed to be spreading, based on a tissue sample.
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I am 18 years old or older.
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All my cancer spots can be treated with focused radiation because they are small enough.
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My liver, kidney, and blood tests are within normal ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local control rate
Proportion of patients with neurocognitive decline
Secondary outcome measures
Cumulative incidence of local failure
Cumulative incidence of neurocognitive decline
Time to local failure
+1 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702
32%
Fatigue
28%
Lymphocyte count decreased
24%
Cough
20%
Back pain
20%
Rash acneiform
16%
Anorexia
16%
Dry skin
16%
Hyperglycemia
16%
Rash maculo-papular
12%
Aspartate aminotransferase increased
12%
Non-cardiac chest pain
12%
Diarrhea
12%
Dyspepsia
12%
Headache
12%
Nausea
12%
Pain
12%
Pain in extremity
8%
Weight loss
8%
Urinary tract pain
8%
Wheezing
8%
Watering eyes
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Myalgia
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Sore throat
4%
Urinary tract infection
4%
Skin infection
4%
White blood cell decreased
4%
Vomiting
4%
Upper respiratory infection
4%
Urinary urgency
4%
Ear pain
4%
Oral hemorrhage
4%
Conjunctivitis
4%
Alkaline phosphatase increased
4%
Blood bilirubin increased
4%
Bone pain
4%
Bruising
4%
Depression
4%
Dry eye
4%
Dysgeusia
4%
Dysphagia
4%
Edema face
4%
Epistaxis
4%
Flashing lights
4%
Flu like symptoms
4%
Gastroesophageal reflux disease
4%
Hot flashes
4%
Hyperkalemia
4%
Hypernatremia
4%
Infusion site extravasation
4%
Insomnia
4%
Lethargy
4%
Nail loss
4%
Nail ridging
4%
Neck pain
4%
Neutrophil count decreased
4%
Papulopustular rash
4%
Platelet count decreased
4%
Pneumonitis
4%
Fracture
4%
Fall
4%
Skin hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Radiosurgery Followed by Erlotinib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (WBRT)Experimental Treatment3 Interventions
Patients undergo WBRT 5 days per week (7 days per week for inpatients) for 2 weeks.
Group II: Arm I (SRS)Experimental Treatment3 Interventions
Patients undergo SRS on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,377 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,613 Previous Clinical Trials
40,918,217 Total Patients Enrolled
Jing LiPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
51,609 Total Patients Enrolled

Media Library

Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01592968 — Phase 3
Brain Metastasis Research Study Groups: Arm I (SRS), Arm II (WBRT)
Brain Metastasis Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT01592968 — Phase 3
Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01592968 — Phase 3

Frequently Asked Questions

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

Are patients currently being recruited for this trial?

"According to the clinicaltrials.gov listing, this study has wrapped up recruitment as of August 18th, 2022. The trial was first posted on 8/2/2012. Although this specific study is not enrolling patients, there are 2844 other trials with open enrollment at this time."

Answered by AI

Has Stereotactic Radiosurgery undergone rigorous testing by the FDA?

"There is a fair amount of data attesting to the safety of Stereotactic Radiosurgery, so it received a score of 3."

Answered by AI

What are the aims of this research?

"This trial will aim to observe the proportion of patients that experience neurocognitive decline over a 4 month period. Additionally, this study will secondary track the time to neurocognitive decline (as measured by HVLT-R score), cumulative incidence of local failure, and cumulative incidence of neurocognitive decline."

Answered by AI
~10 spots leftby Sep 2025