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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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My brain tumors are no larger than 3 cm.
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I have up to 3 new brain metastases and had surgery to remove one.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to local recurrence
Secondary outcome measures
Development of distant brain metastases
Incidence of complications related to treatment
Overall survival
+3 moreSide effects data
From 2019 Phase 2 trial • 32 Patients • NCT0157370232%
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%
Wheezing
8%
Watering eyes
8%
Urinary tract pain
8%
Myalgia
8%
Weight loss
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%
White blood cell decreased
4%
Sore throat
4%
Urinary tract infection
4%
Skin infection
4%
Lethargy
4%
Infusion site extravasation
4%
Urinary urgency
4%
Vomiting
4%
Insomnia
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
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
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,649 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,021 Total Patients Enrolled
Debra NAna YeboaPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My primary cancer is either small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.I am a candidate for focused radiation therapy within 30 days after surgery.I can care for myself but may not be able to do active work or play.I am older than 3 years.The area where my tumor was removed is 4cm wide or smaller.My brain tumors are no larger than 3 cm.I have up to 3 new brain metastases and had surgery to remove one.I have had radiation therapy to my brain before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (SRS)
- Group 2: Arm II (observation)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How perilous is the Arm I (SRS) treatment for patients?
"Our team has assessed that Arm I (SRS) is of a comparatively high safety rating, 3 out of 3, due to the precedent set by Phase 3 trials in terms of efficacy and data-backed security."
Answered by AI
Are there any open slots available for enrolment in this research study?
"Verification of clinicaltrials.gov reveals that this particular medical study is no longer recruiting patients, having first been posted on 13th August 2009 and last updated on 24th February 2023. Despite this, there are still 2391 active trials open to new participants at the moment."
Answered by AI
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