Stereotactic Body Radiation Therapy (SBRT) for Bone Diseases

1
Effectiveness
2
Safety
Dana Farber Cancer Institute, Boston, MA
Bone Diseases+3 More
Stereotactic Body Radiation Therapy (SBRT) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Bone Diseases

Study Summary

This study is evaluating whether a form of radiation therapy may be helpful for individuals with cancer that has spread to the spine or other bone.

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Eligible Conditions

  • Bone Diseases
  • Osteosarcoma
  • Bone Cancer
  • Cancer Bone
  • Bone Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Stereotactic Body Radiation Therapy (SBRT) will improve 1 primary outcome and 5 secondary outcomes in patients with Bone Diseases. Measurement will happen over the course of 3 months.

1 year
Local Progression-Free Survival
Overall Survival
Patient Reported Quality of Life - Chronic
Progression-Free Survival
3 months
Patient Reported Quality Of Life - Acute
6 months
Evaluate The Local Control Rate Of SBRT

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

No Control Group
Oligometastatic Disease

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stereotactic Body Radiation Therapy (SBRT) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Oligometastatic DiseaseStereotactic 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
Metastatic DiseaseStereotactic 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2014
Completed Phase 2
~630

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Who is running the study

Principal Investigator
T. B.
Tracy Balboni, MD
Dana-Farber Cancer Institute

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No other cancer, except for non-melanoma skin cancers or carcinoma in situ of the cervix, within the past 2 years. show original
was required by the IRB The IRB required that ability to understand and willingness to sign a written informed consent document be present in order for the study to be approved. show original
If the lesion is smaller than a certain size, surgery is allowed. show original
I am not currently pregnant or breast feeding. show original
In Cohort 1, 15 patients had an oligometastatic state, defined as a single metastatic lesion that was resected with curative intent show original
An oligometastatic state is one in which there are only a few active metastatic sites, typically no more than three show original
You must be at least 18 years of age to purchase this product. show original
The patient's ECOG performance status is ≤2. show original
treated with radiation therapy as the sole modality A solid tumor that has spread to the bone and is not a blood cancer is treated with radiation therapy alone. show original
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. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who should consider clinical trials for bone diseases?

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These data suggest that patients who are medically stabilized and who are still eligible for clinical trials should be considered to participate in clinical trials.

Unverified Answer

Has stereotactic body radiation therapy (sbrt) proven to be more effective than a placebo?

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If a patient would choose to have SBRT, then that is the best care available currently. No significant difference in outcome was observed between patients receiving SBRT and those receiving a placebo.

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What are the latest developments in stereotactic body radiation therapy (sbrt) for therapeutic use?

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Surgical techniques, and, in particular, the use of the Cyberknife SBRT system, are continually adapting; these technologies have the potential for further improvement and refinement, and are already being applied in clinical practice in several countries. Some issues remain to be resolved.

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What causes bone diseases?

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Bone diseases can be caused by multiple factors, including mechanical disruption due to osteoclastic or osteoblastic activity, as in case of osteoporosis and [bone cancer](https://www.withpower.com/clinical-trials/bone-cancer), respectively. In addition, bone diseases can be caused by a generalized hypomineralized metabolism induced by factors affecting phosphate metabolism, such as cancer-related factors or malabsorption. The term "skeletal disease" is often used as a synonym for bone disease which is incorrect; it is not necessarily the case that bone diseases are diseases of the skeleton. A diagnosis of a bone disease should consider the cause of the disease and the specific treatment.

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What are common treatments for bone diseases?

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Common treatments for bone diseases such as bone metastases and bone cancer include medical, surgical, and/or radiation therapy. These treatments can be used alone or together. Bone metastases often have an extremely poor prognosis, and treatments aim to minimize the pain to allow for quality of life and prolong survival. However, these same treatments have adverse side effects and can worsen the condition of the patient. Therefore, patient choices are key for treatment selection. More research is recommended to improve the current treatments for bone diseases.

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What is bone diseases?

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As osteoporosis and osteopenia affect more than 1 in 2 women and 1 in 5 men, bone diseases are recognized as an important public health issue. This article describes the clinical features of and diagnostic test results for osteoporosis.

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What are the signs of bone diseases?

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Bones may exhibit pain and swelling, which may occur at sites such as shoulder and knee, or pain along the spine, or pain in one hip or leg. Fractures of certain bones in children may be not be as notificable, as children may not have pain, swelling or mobility issues, and it may take a long time for an X ray to be taken. Children also may have other conditions which may interfere with their ability to take X-rays.\n\nPediatric Emergency Medicine\n\nThe purpose of this article is to list symptoms of a wide range of illnesses and conditions in children. None of the symptoms should be considered specific to any single medical condition.

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Can bone diseases be cured?

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Findings from a recent study in this study support the concept that some osteoporotic bone diseases can be effectively cured; these include osteopenia, osteoporosis, and osteopetrosis of the femur, spine, and other sites.

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How many people get bone diseases a year in the United States?

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The cumulative incidence of osteoporosis, osteopenia and chronic spine pain are high at any given age. In particular, the rate is increased twofold or more in women between the ages of 50 and 64 who did not have osteoporosis as children. Furthermore, if we had assumed that osteoporosis affects every first degree relative between 20 and 49 years, then an assumption of 20% to 24% of this cumulative incidence is justified. These data offer a new basis for population-based prevention programmes.

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Have there been other clinical trials involving stereotactic body radiation therapy (sbrt)?

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As of early 2016, there was no evidence of a difference in effectiveness between SBRT and conventional treatments for spine metastases without severe neurological deficits. Because the randomized controlled trials reported in this review used different patient groups, different criteria for spinal cord dysfunction, a different imaging definition of neurological deficit and a different review period, this evidence is inconclusive with regard to the effectiveness of SBRT. Additional high-quality studies are needed.

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What is the primary cause of bone diseases?

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The majority of patients surveyed reported osteoporosis (54%) or osteopenia (30%) as their primary cause of bone diseases. Other causes, such as other endocrine disorders, nutritional deficiencies, hematologic disorders, hypothyroidism, hyperparathyroidism, hyperparathyroidism due to vitamin D deficiencies, rheumatic disease, and osteitis pubioptica, were described less frequently.

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Have there been any new discoveries for treating bone diseases?

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The last few years of new findings are very exciting, and many diseases such as [Tuberculosis] are being treated and cured for the first time. In the future, we must only focus on the diseases, medicines, and treatments. In many autoimmune disease treatments, it seems as if there are a lot of discoveries being made. We have to continue to get a grip on our minds and keep the discoveries coming.

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