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Radiation Therapy

Stereotactic Radiosurgery for Brain Cancer

Phase 3
Waitlist Available
Led By Debra NAna Yeboa
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
Patients must have a Karnofsky Performance Scores (KPS) of at least 70 at the first post operative visit. Patients under 18 years of age must have a Lansky Performance Score of of at least 70
Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3)
Must not have
The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma
Patients who have received prior radiation therapy to the brain for any reason
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies a type of radiation therapy to see if it can treat brain cancer better than surgery alone.

Who is the study for?
This trial is for patients over 3 years old with brain metastases who've had surgery to remove at least one tumor. They must have a good performance status, be able to undergo an MRI, and can't have had previous brain radiation or certain cancers like small-cell lung cancer. Pregnant or breastfeeding women are excluded.
What is being tested?
The study compares stereotactic radiosurgery (SRS)—a precise form of radiation therapy—with just watching the patient after they've had surgery for brain tumors. The goal is to see if SRS offers better outcomes than not treating further.
What are the potential side effects?
While not detailed here, side effects of SRS may include headaches, fatigue, hair loss at treatment site, nausea, and potential short-term swelling around the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do active work or play.
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I am older than 3 years.
Select...
My brain tumors are no larger than 3 cm.
Select...
I have up to 3 new brain metastases and had surgery to remove one.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My primary cancer is either small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
Select...
I have had radiation therapy to my brain before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to local recurrence
Secondary study objectives
Development of distant brain metastases
Incidence of complications related to treatment
Overall survival
+3 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%
Urinary tract pain
8%
Watering eyes
8%
Weight loss
8%
Myalgia
8%
Wheezing
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Upper respiratory infection
4%
Vomiting
4%
Urinary tract infection
4%
White blood cell decreased
4%
Lethargy
4%
Sore throat
4%
Skin infection
4%
Urinary urgency
4%
Insomnia
4%
Infusion site extravasation
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%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (SRS)Experimental Treatment1 Intervention
Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy.
Group II: Arm II (observation)Active Control1 Intervention
Patients undergo clinical observation after craniotomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2021
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,459 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,948 Total Patients Enrolled
Debra NAna YeboaPrincipal InvestigatorM.D. Anderson Cancer Center
Erik P SulmanPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00950001 — Phase 3
Brain Metastasis Research Study Groups: Arm I (SRS), Arm II (observation)
Brain Metastasis Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT00950001 — Phase 3
Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00950001 — Phase 3
~3 spots leftby Apr 2025
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