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Radiation Therapy
Single-Fraction Radiation for Spine Lesions
Phase 1
Waitlist Available
Led By Yoshiya Yamada, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
KPS ≥ 60%
Patients must have histologic or cytologic proof of a non-hematologic malignancy confirmed by MSKCC pathologic review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if single-fraction radiation therapy can help patients with spine and cauda equina lesions that have progressed after initial radiation therapy.
Who is the study for?
This trial is for adults over 18 with non-blood related cancers that have spread to the spine or cauda equina and worsened after previous radiation. They must have had prior radiation at least 6 months ago, a KPS score of at least 60%, and their cancer should be confirmed by pathology review. Excluded are those with less than a six-month life expectancy, certain blood count issues, recent bevacizumab treatment, specific spinal conditions, planned chemotherapy around re-irradiation time, inability to undergo imaging tests required for the study or if they're pregnant.Check my eligibility
What is being tested?
The trial is testing single-fraction stereotactic radiosurgery on patients whose spine lesions from cancer have progressed despite earlier radiation therapy. It uses advanced imaging like MRI/CT for guidance and will explore three different doses to find out which one is safe and effective.See study design
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site, fatigue, nausea, inflammation of surrounding tissues or organs due to high-dose radiation exposure. There might also be risks associated with sedation needed for some procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
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My cancer diagnosis has been confirmed by a pathology review.
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I had radiation therapy in the same area where I'm now planned for a focused re-irradiation, at least 6 months ago.
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My spinal tumor has grown or worsened on recent scans.
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My target lesion for re-irradiation is smaller than 2 vertebral bodies.
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I am 18 years old or older.
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My cancer has spread to my spine or lower back and can be treated with radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria
Secondary outcome measures
local failure
overall survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: single-fraction radiosurgeryExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,613 Total Patients Enrolled
Yoshiya Yamada, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
359 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread near my spine but not to the lower spine or sacral area.My blood does not clot properly, and I can't safely stop my blood thinners for the procedure.I had radiation therapy in the same area where I'm now planned for a focused re-irradiation, at least 6 months ago.My cancer has spread around my spinal cord.I can care for myself but may need occasional help.My tumor is very close to or inside my spinal cord.I am scheduled for or have had chemotherapy around the same time as my targeted brain radiation.I have not taken bevacizumab in the last 12 weeks.My cancer diagnosis has been confirmed by a pathology review.My spinal tumor has grown or worsened on recent scans.My target lesion for re-irradiation is smaller than 2 vertebral bodies.I am 18 years old or older.My spinal cord has received less than 100 Gy of radiation in total.My cancer has spread to my spine or lower back and can be treated with radiation.My treatment plan does not exceed safe radiation levels.I cannot receive effective doses through external beam for my lesion according to guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: single-fraction 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 regulatory clearances for single-dose irradiation?
"Considering the limited data on efficacy and safety, single-fraction radiation was assigned a score of 1."
Answered by AI
Is this trial currently searching for participants?
"Clinicaltrials.gov reveals that this research project, initially posted on October 27th 2014, is no longer accepting participants. Nevertheless, there are alternate clinical trials actively seeking recruits at present."
Answered by AI
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