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Radiation Therapy
Stereotactic Radiosurgery for Brain Metastasis
Phase 2
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 histologic evidence suggesting small cell lung cancer. Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc.). Cytology-alone is not an acceptable method of diagnosis.
Patients must have Eastern Cooperative Oncology Group (ECOG) =< 3
Must not have
Female patients of childbearing age are excluded if they are pregnant as determined with a urine or serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breast-feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating whether stereotactic radiosurgery, which only targets areas of the brain affected by the disease, is better than whole brain radiation therapy at preserving brain function in small cell lung cancer patients with brain metastasis.
Who is the study for?
This trial is for English-speaking patients with small cell lung cancer that has spread to the brain, who have not had prior brain radiation therapy. They must be physically able to participate (ECOG <=3), have 10 or fewer brain metastases, and no history of psychiatric/neurologic illness affecting cognition. Pregnant or breastfeeding women are excluded.
What is being tested?
The trial studies stereotactic radiosurgery's effect on brain function in treating brain metastasis from small cell lung cancer. It compares this targeted approach to standard whole-brain radiation therapy, aiming to reduce nervous system side effects.
What are the potential side effects?
Stereotactic radiosurgery may cause headaches, nausea, fatigue, hair loss at treatment site, and short-term memory issues. Long-term risks include weakness or numbness in parts of the body controlled by the treated area of the brain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
My diagnosis of small cell lung cancer is confirmed through tissue samples.
Select...
I can take care of myself but may not be able to do heavy physical work.
Select...
I have not had radiation therapy to my brain.
Exclusion Criteria
You may be eligible for the trial if you check βNoβ for criteria below:Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Secondary study objectives
Change in neurocognitive score
Cognitive decline
Distant tumor control rate
+10 moreSide effects data
From 2019 Phase 2 trial β’ 32 Patients β’ 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%
Myalgia
8%
Urinary tract pain
8%
Weight loss
8%
Watering eyes
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%
Sore throat
4%
Vomiting
4%
Urinary urgency
4%
Urinary tract infection
4%
Upper respiratory infection
4%
Skin infection
4%
White blood cell decreased
4%
Insomnia
4%
Lethargy
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (SRS)Experimental Treatment2 Interventions
Patients undergo SRS in the absence of disease progression or unacceptable toxicity. Patients whose disease progresses may be treated with additional courses of SRS per physician discretion.
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?
National Cancer Institute (NCI)NIH
13,926 Previous Clinical Trials
41,017,962 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,591 Total Patients Enrolled
Jing LiPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
51,677 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a history of metastatic cancer other than small cell, or any uncontrolled non-metastatic cancer.I do not have a psychiatric or neurological illness affecting my thinking, except if it's due to brain metastasis.My doctor has assessed my ability to perform daily activities.You cannot participate if tests find cancer cells in your spinal fluid.My diagnosis of small cell lung cancer is confirmed through tissue samples.Having circulating tumor DNA in the cerebrospinal fluid (CSF) does not prevent participation in the study.You cannot participate if tests show that you have leptomeningeal disease.I am not pregnant or breastfeeding.I can take care of myself but may not be able to do heavy physical work.I have not had radiation therapy to my brain.I have 10 or fewer brain tumors, confirmed by a recent MRI.All my cancer lesions can be treated with targeted radiation.Your blood clotting test should show normal results within 28 days before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SRS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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