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Radiation Therapy
Thermal Ablation and Radiosurgery for Spinal 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying whether thermal ablation and spine stereotactic radiosurgery can help treat patients with cancer that has spread to the spine.
Who is the study for?
This trial is for adults with certain types of cancer that has spread to the spine, risking spinal cord compression. Eligible patients have a life expectancy over 3 months, can't be pregnant, and must agree to use contraception. They should not have had recent radiation or surgery at the same spine level and must be able to lie flat for treatment.
What is being tested?
The study tests combining thermal ablation (using heat to destroy tumor cells) with stereotactic radiosurgery (targeted high-dose radiation sparing healthy tissue) in treating spinal metastases that could compress the spinal cord.
What are the potential side effects?
Potential side effects may include discomfort or pain at the ablation site, skin burns, nerve damage around treated area leading to weakness or numbness, and typical radiation exposure risks like fatigue and localized skin reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Local tumor control rate
Secondary study objectives
Changes in quality of life (QOL) assessed by Brief pain inventory (BPI) form
Changes in quality of life (QOL) assessed by SF-12 healthy survey (v2)
Vertebral column
+5 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%
Myalgia
8%
Urinary tract pain
8%
Watering eyes
8%
Weight loss
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%
White blood cell decreased
4%
Insomnia
4%
Lethargy
4%
Skin infection
4%
Sore throat
4%
Upper respiratory infection
4%
Urinary tract infection
4%
Urinary urgency
4%
Vomiting
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 (thermal ablation, SSRS)Experimental Treatment5 Interventions
Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Stereotactic Radiosurgery
2021
Completed Phase 2
~440
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,968 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,063 Previous Clinical Trials
1,800,721 Total Patients Enrolled
Jing LiPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
51,672 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have no more than 3 areas in your spine with cancer spread that need radiation treatment.The abnormal areas are not located between the second and twelfth bones of your spine.You have severe compression on your spinal cord, causing acute problems with movement and strength in your limbs.You have good muscle strength in the affected body parts, scoring at least 4 out of 5 on a strength scale.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (thermal ablation, SSRS)
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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