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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Life expectancy >3 months
Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up1, 3, 6, 9, 12, 18, and 24 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new way to treat tumors near the spinal cord by combining two existing treatment methods. The goal is to improve tumor control and quality of life for patients with spinal metastasis.
Eligible Conditions
- Spinal Metastases
- Cancer
- Spinal Cord Disease
- Spinal Cord Compression
- Spinal Cord Tumors
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are expected to live for at least 3 more months.
Select...
You have been diagnosed with a solid cancer tumor, such as lung, breast, prostate, kidney, skin, stomach, bone, thyroid, head and neck, or an unknown origin tumor.
Select...
Your MRI shows a certain level of spinal cord compression.
Select...
The area of the spine that needs treatment is between the T2 and L1 vertebrae.
Select...
You can't have more than 3 areas in your spine with cancer that need to be treated with radiation at one time or over three sessions.
Select...
Your affected arms or legs have strong muscle strength, rated 4 out of 5 or higher.
Select...
You are able to perform daily activities without help, or your overall health is fairly good.
Select...
You had radiation treatment at the same place more than 3 months ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, 6, 9, 12, 18, and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 9, 12, 18, and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local Tumor Control Rate
Secondary outcome measures
Adverse Events
Neurologic Examination
Changes in symptoms assessed by physical examination
+3 moreOther outcome measures
Measuring Quality of life (QOL) assessed by Brief Pain Inventory Survey (BPI)
Measuring Quality of life (QOL) assessed by Health Survey (SF-36)
Measuring Quality of life (QOL) assessed by Spine Tumor Survey (MDASI-SP)
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%
Watering eyes
8%
Weight loss
8%
Wheezing
8%
Urinary tract pain
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%
Urinary tract infection
4%
Sore throat
4%
Vomiting
4%
Urinary urgency
4%
Upper respiratory infection
4%
White blood cell decreased
4%
Skin infection
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
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: Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic RadiosurgeryExperimental Treatment3 Interventions
Patients will undergo laser interstitial thermal ablation and CT guided stereotactic radiosurgery via intensity-modulated radiation therapy on different dates within a one to fourteen day window. The order of treatment is at the treating physicians discretion.
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?
Henry Ford Health SystemLead Sponsor
294 Previous Clinical Trials
2,434,814 Total Patients Enrolled
MedtronicIndustry Sponsor
599 Previous Clinical Trials
829,189 Total Patients Enrolled
Ian Lee, MDPrincipal InvestigatorHenry Ford Health Health System
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can't handle being put to sleep or lying face down.You need to have a spinal procedure done with or without image guidance.You have certain types of tumors that are sensitive to radiation therapy, like lymphoma or small cell carcinoma.You cannot have a magnetic resonance imaging (MRI) scan of your spine.You cannot lie down flat on a table for more than 60 minutes.You are expected to live for at least 3 more months.The area of the spine that needs treatment is between the T2 and L1 vertebrae.You are able to perform daily activities without help, or your overall health is fairly good.You have received radiation treatment to the same area of the spine less than 3 months ago.You have severe spinal cord compression causing acute problems with moving your arms or legs.You have been diagnosed with a solid cancer tumor, such as lung, breast, prostate, kidney, skin, stomach, bone, thyroid, head and neck, or an unknown origin tumor.Your MRI shows a certain level of spinal cord compression.You can't have more than 3 areas in your spine with cancer that need to be treated with radiation at one time or over three sessions.Your affected arms or legs have strong muscle strength, rated 4 out of 5 or higher.You had radiation treatment at the same place more than 3 months ago.You must be 18 years old or older. This technique might not be safe for younger people whose bones are still growing.You have been diagnosed with a solid cancer that is not highly sensitive to radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery
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 there any vacancies for participants in this investigation?
"Affirmative. According to clinicaltrials.gov, this research is still actively gathering participants for the experiment. The project was first announced on September 2nd 2021 and most recently updated July 26th 2022 with the intention of recruiting 60 test subjects from a single site."
Answered by AI
What is the estimated sample size for this medical trial's participants?
"Affirmative. The information hosted on clinicaltrials.gov implies that this experiment is actively recruiting participants, having been initially published on September 2nd 2021 and last amended on July 26th 2022. 60 patients are sought to take part at 1 site."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Michigan
How old are they?
18 - 65
What site did they apply to?
Henry Ford Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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