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Radiation Therapy
Stereotactic Radiosurgery for 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is studying whether thermal ablation and spine stereotactic radiosurgery can help treat patients with cancer that has spread to the spine.
Eligible Conditions
- Spinal Metastasis
- Gastrointestinal Cancer
- Sarcoma
- Head and Neck Cancers
- Spinal Cord Compression
- Cancer
- Tumors
- Prostate Cancer
- Melanoma
- Breast Cancer
- Thyroid Cancer
- Non-Small Cell Lung Cancer
- Kidney Cancer
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
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
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%
Wheezing
8%
Watering eyes
8%
Urinary tract pain
8%
Weight loss
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Upper respiratory infection
4%
White blood cell decreased
4%
Sore throat
4%
Urinary tract infection
4%
Skin infection
4%
Lethargy
4%
Infusion site extravasation
4%
Urinary urgency
4%
Vomiting
4%
Insomnia
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
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
~2720
Thermal Ablation Therapy
2016
Completed Phase 2
~60
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,607 Total Patients Enrolled
1 Trials studying Metastasis
2 Patients Enrolled for Metastasis
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,742 Total Patients Enrolled
Jing LiPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
51,637 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.
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 in this trial for participants?
"Affirmative. From clinicaltrials.gov, we can see that this research is actively searching for individuals to participate in their trial. Initially posted on August 29th 2016 and modified most recently on September 22nd 2022, the team requires 60 participants at one site."
Answered by AI
What is the current participation rate of this medical experiment?
"Affirmative, the information on clinicaltrials.gov states that this experiment is actively enlisting individuals for participation. The research was originally published on August 29th 2016 and received its most recent revision on September 22nd 2022. A total of 60 participants must be recruited at a single location."
Answered by AI
Is Stereotactic Radiosurgery a hazardous medical treatment?
"Our group at Power rated the safety of Stereotactic Radiosurgery a 2, as there is some empirical evidence to back up its security but none that can demonstrate it's efficacy."
Answered by AI
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