← Back to Search

Radiation

Radiation Therapy for Bone Metastases

Phase 3

Recruiting

Led By Quynh Nguyen, M D

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

Patients with prior surgery for osseous metastases are eligible.

Patients age 18 years or older. Pediatric patients are usually enrolled on pediatric protocols. There are no adverse data available for patients < 18 years of age treated with SBRT, therefore children are excluded from this study.

Must not have

Patients with previously treated with radioactive isotope (e.g. Sr 89) within 30 days of randomization. This can have concomitant effects with radiation therapy.

Patient with current, un-treated cord compression at treatment site.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare different doses and timing of radiation therapy to a standard treatment for cancer.

Who is the study for?

This trial is for adults with solid primary malignancies and bone metastases, who have a life expectancy of at least 3 months. They must have adequate organ function, agree to use contraception if of childbearing potential, and be able to complete surveys. Excluded are pregnant individuals, those with prior radiation or certain treatments at the site, spinal metastases not invading paraspinal region or mechanically unstable fractures.

What is being tested?

The study tests different doses and schedules of stereotactic body radiation therapy (SBRT) against standard palliative radiation therapy in patients with painful bone metastases. The goal is to see which method better manages pain while considering patient quality of life.

What are the potential side effects?

Potential side effects include skin reactions at the treatment site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. There may also be acute pain flare-ups following treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had surgery for bone metastases.

Select...

I am 18 years old or older.

Select...

My platelet count is at least 40,000 per microliter.

Select...

I feel pain or discomfort where I might receive treatment.

Exclusion Criteria

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

Select...

I have not had treatment with radioactive isotopes like Sr 89 in the last 30 days.

Select...

I have a spinal cord compression that hasn't been treated yet.

Select...

My cancer has spread to my hands or feet.

Select...

I have had radiation therapy on the area to be treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 - High DoseExperimental Treatment1 Intervention

Participants will receive either 1 radiation treatment a day for 5 days, or 1 radiation treatment given on 1 day.

Group II: Arm 1 - Standard DoseExperimental Treatment1 Intervention

Participants will receive either 1 radiation treatment a day for 3 days in a row (not counting weekends or holidays), or Participants will receive 1 radiation treatment given on 1 day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 8Eligibility criteria met