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.
Eligible Conditions
- Metastatic Malignant Neoplasm
- Brain
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: Up to 12 months
At 4 months
Local control rate
Proportion of patients with neurocognitive decline
Up to 12 months
Cumulative incidence of local failure
Cumulative incidence of neurocognitive decline
Time to local failure
Time to neurocognitive decline
Trial Safety
Safety Progress
This is further along than 85% 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
Trial Design
2 Treatment Groups
Arm I (SRS)
1 of 2
Arm II (WBRT)
1 of 2
Experimental Treatment
88 Total Participants · 2 Treatment Groups
Primary Treatment: Stereotactic Radiosurgery · No Placebo Group · Phase 3
Arm I (SRS)Experimental Group · 3 Interventions: Stereotactic Radiosurgery, Cognitive Assessment, Quality-of-Life Assessment · Intervention Types: Radiation, Other, Other
Arm II (WBRT)Experimental Group · 3 Interventions: Cognitive Assessment, Whole-Brain Radiotherapy, Quality-of-Life Assessment · Intervention Types: Other, Radiation, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2012
Completed Phase 2
~320
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,783 Previous Clinical Trials
1,784,770 Total Patients Enrolled
19 Trials studying Metastatic Malignant Neoplasm
3,828 Patients Enrolled for Metastatic Malignant Neoplasm
National Cancer Institute (NCI)NIH
13,005 Previous Clinical Trials
41,301,839 Total Patients Enrolled
25 Trials studying Metastatic Malignant Neoplasm
3,312 Patients Enrolled for Metastatic Malignant Neoplasm
Jing LiPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
50,998 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:All patients enrolled in this study must have at least 3 but no more than 15 metastatic lesions seen on a contrast enhancing MRI scan obtained not less than one month prior to study enrollment
This study is experimental and all patients must sign an informed consent form stating that they are aware of this
Patients can be taking concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist.
The text states that in order to be a patient at the cancer center, one must have histological proof of malignant cancer
All patients must have normal liver, renal, and hematologic function as defined by Aspartate Amino Transferase (AST)/Alanine Amino Transferase (ALT)/Alkaline Phosphatase < 2.5 times normal, calculated creatinine clearance > 30ml/min, and platelet count > 50,000.
All patients should have normal coagulation, with international normalized ratio (INR) < 1.3 and be able to withhold anti-coagulation medications a minimum of 24 hours prior to radiosurgery (or until INR normalizes), on the day of treatment and 24 hours after radiosurgery has concluded
Any person seeking medical care must be 18 years of age or older.
All patients must be eligible to have lesions treated with SRS
About The Reviewer
Michael Gill - B. Sc.
First Published: October 23rd, 2021
Last Reviewed: November 13th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments