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Radiation Therapy
Stereotactic Radiosurgery for Melanoma Brain Metastases
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 with histologic proof of malignant melanoma. 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 be eligible to have all lesions treated as determined by the study radiation oncologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial looks at how well stereotactic radiosurgery works to treat patients with melanoma that has spread to the brain.
Who is the study for?
This trial is for melanoma patients with more than three brain metastases confirmed by MRI. They must have normal kidney function, blood platelet count, and coagulation levels; be able to pause certain medications around treatment time; and not be pregnant or breastfeeding. Patients previously treated with whole-brain radiotherapy or those with additional cancers are excluded.Check my eligibility
What is being tested?
The study tests stereotactic radiosurgery's effectiveness on patients with multiple melanoma brain metastases. This precise radiation therapy targets tumors directly in a single high dose, potentially sparing healthy tissue.See study design
What are the potential side effects?
Stereotactic radiosurgery may cause headaches, fatigue, nausea, hair loss at the treatment site, swelling in the brain which can lead to neurological issues, and very rarely seizures or hemorrhage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma diagnosis was confirmed through tissue examination.
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All my cancer lesions can be treated, as confirmed by a radiation oncologist.
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I have more than 3 melanoma brain tumors as shown in my recent MRI.
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My blood clotting is normal and I can stop blood thinners for radiosurgery.
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I am currently receiving other cancer treatments as decided by my doctor.
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I am mostly able to care for myself and carry out daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to neurocognitive failure
Time to progression
Secondary outcome measures
Neurocognitive function score
Number of cycles of systemic chemotherapy given following radiation treatment
Overall survival
Side 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%
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%
Skin infection
4%
Urinary tract 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
1Treatment groups
Experimental Treatment
Group I: Treatment (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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,400 Total Patients Enrolled
102 Trials studying Melanoma
25,295 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,597 Total Patients Enrolled
557 Trials studying Melanoma
193,184 Patients Enrolled for Melanoma
Jing LiPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
51,648 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count is higher than 50,000.My melanoma diagnosis was confirmed through tissue examination.All my cancer lesions can be treated, as confirmed by a radiation oncologist.I have not had whole brain radiotherapy in the last 3 months.I have more than 3 melanoma brain tumors as shown in my recent MRI.Your kidneys work well enough to clear out waste from your body.My blood clotting is normal and I can stop blood thinners for radiosurgery.I do not have cancer spread to the lining of my brain or spinal cord.I am currently receiving other cancer treatments as decided by my doctor.You cannot have had an allergic reaction to gadolinium in the past.I am mostly able to care for myself and carry out daily activities.I do not have a history of cancer spreading beyond melanoma or any uncontrolled cancer.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications accepted for this experiment currently?
"This clinical trial, first announced on August 2nd 2012, is not presently looking for participants. However, 3402 other medical studies are recruiting patients at this time according to information provided by clinicaltrials.gov."
Answered by AI
Is Stereotactic Radiosurgery a safe procedure for those under its care?
"Our team has appraised Stereotactic Radiosurgery's safety to be a 2, as this is still an experimental Phase 2 trial with some evidence of its harmlessness but no proof of efficacy."
Answered by AI
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