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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

Must not have

Prior RT of greater dose intensity than 100 Gy2 based on a biological effective dose (BED) calculation

Requirement of active receipt of systemic therapies concurrent with SBRT (concurrent hormonal therapies are allowed)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am 18 years old or older.

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My cancer spread to bones is less than 6 cm and affects no more than 3 spine bones.

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My cancer has spread to 3 or fewer places, including where it started.

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I've had radiation before in the area where my disease is now.

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My cancer has spread to my bones.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received radiation therapy with a dose higher than 100 Gy2.

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I am currently receiving treatment for my cancer that involves medication taken by mouth or injection.

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I can't stay still for treatments even with medication for anxiety or pain.

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My treatment target is larger than 6 cm or 100 cc.

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My spinal tumor is very close to the spinal cord.

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I have a blood cancer such as lymphoma or multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The 6-month Local Control Rate of SBRT

Secondary study objectives

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 more

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593

21%

Anemia

18%

Neutropenia

15%

Hypoalbuminemia

15%

White blood cell decreased ( leukopenia)

15%

Diarrhea

12%

Liver Dysfunction

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

Study treatment Arm

Gem + Xeloda + SBRT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~950

0 / 12Eligibility criteria met