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Radiation Therapy
SBRT for Bone Cancer
Phase 2
Waitlist Available
Led By Tracy Balboni, MD MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Bony metastatic lesions must be ≤6 cm in maximum dimension and evaluable on either a CT or MRI scan; metastatic lesions in the spine must involve ≤3 contiguous vertebral bodies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
Study Summary
This trial is studying how well SBRT works in treating cancer that has spread to the spine or other bones.
Who is the study for?
This trial is for adults over 18 with bone cancer that has spread to the spine or other bones, but not more than three places. They should be in good enough health to sign consent and have a life expectancy of over 3 months. Pregnant women, those with blood cancers, recent other cancers (except certain skin cancers and cervical cancer in situ), or who can't lie still for treatment are excluded.Check my eligibility
What is being tested?
The study tests Stereotactic Body Radiation Therapy (SBRT) using a Stereotactic Linear Accelerator on patients with limited metastatic bone disease. It aims to see if this targeted radiation therapy is effective for treating small areas where cancer has spread to the bones.See study design
What are the potential side effects?
Potential side effects include pain at the radiation site, fatigue, skin reactions similar to sunburns, nausea, and inflammation around treated bones. There may also be risks associated with previous treatments interacting with SBRT.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My cancer spread to bones is less than 6 cm and affects no more than 3 spine bones.
Select...
My cancer has spread to 3 or fewer places, including where it started.
Select...
I've had radiation before in the area where my disease is now.
Select...
My cancer has spread to my bones.
Select...
I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The 6-month Local Control Rate of SBRT
Secondary outcome measures
2-year Overall Survival Rate
Number of Participants With 1-year Local Progression-Free Survival
Number of Participants With 2-year Progression-Free Survival
+2 moreSide effects data
From 2018 Phase 2 trial • 35 Patients • NCT0136059321%
Anemia
18%
Neutropenia
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Diarrhea
12%
Liver Dysfunction
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem + Xeloda + SBRT
Trial Design
2Treatment groups
Experimental Treatment
Group I: Re-irradiation to Metastatic DiseaseExperimental Treatment2 Interventions
Stereotactic Body Radiation Therapy (SBRT) to site(s) of disease occurring in the bone or spine
Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top.
Dosage will be determined by physician
Group II: Oligometastatic DiseaseExperimental Treatment2 Interventions
Stereotactic Body Radiation Therapy (SBRT)to up to 3 sites of disease occurring in the bone or spine
Treatments will be delivered on a dedicated stereotactic linear accelerator that includes onboard conebeamCT imaging and orthogonal 2D/3D matching with robotic couch top.
Dosage will be determined by physician
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,722 Total Patients Enrolled
Tracy Balboni, MD MPHPrincipal Investigator - Dana-Farber Cancer Institute
Brigham & Women's Hospital, Brigham and Women's Physicians Organization, Dana-Farber Cancer Institute
Harvard Medical Sch (Medical School)
Lahey-Hitchcock Cli (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer spread to bones is less than 6 cm and affects no more than 3 spine bones.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 2 years.My cancer has spread to 3 or fewer places, including where it started.I've had radiation before in the area where my disease is now.I have received radiation therapy with a dose higher than 100 Gy2.I am currently receiving treatment for my cancer that involves medication taken by mouth or injection.I can't stay still for treatments even with medication for anxiety or pain.I can describe my symptoms or have someone who can do it for me.I have been cancer-free for 2 years from a previous cancer, or had certain skin/cervical cancers treated recently.I had surgery on the lesion as long as it met certain size requirements.My cancer has spread to my bones.My treatment target is larger than 6 cm or 100 cc.My spinal tumor is very close to the spinal cord.I am able to care for myself and perform daily activities.My other cancer sites have been or will be treated separately.I have a blood cancer such as lymphoma or multiple myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: Re-irradiation to Metastatic Disease
- Group 2: Oligometastatic Disease
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 patients being accepted into this research study at this time?
"According to the latest information on clinicaltrials.gov, this trial is no longer recruiting patients. The listing was first posted on November 29th, 2016 and was last updated on July 18th, 2022. Although this study isn't looking for any more participants, there are still 172 other trials that are actively recruiting patients."
Answered by AI
Has SBRT undergone the necessary testing to be given FDA approval?
"Because there is only data supporting the safety of Stereotactic Body Radiation Therapy (SBRT) and no data supporting its efficacy, our team at Power has given it a score of 2."
Answered by AI
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