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Radiation

Radiation Therapy for Bone Metastases

Q: What safety measures have been taken to ensure the efficacy of Arm 1 - Standard Dose?

<p>Arm 1 - Standard Dose has been given a rating of 3 due to its Phase 3 trial status, which reveals the existence of data attesting to both safety and efficacy.</p>

Q: Is it still possible to register for this research opportunity?

<p>Contrary to expectation, clinicaltrials.gov suggests that this trial is currently not recruiting participants. Initially posted on February 28th 2024 and last edited on September 26th 2023, the study has yet to open its doors for volunteers--yet 691 other studies are actively doing so at present.</p>

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion: an average of 1year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I have had surgery for bone metastases.

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I am 18 years old or older.

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

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I feel pain or discomfort where I might receive treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion: an average of 1year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion: an average of 1year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion: an average of 1year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,256 Total Patients Enrolled

6 Trials studying Bone Metastases

341 Patients Enrolled for Bone Metastases

Quynh Nguyen, M DPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

What safety measures have been taken to ensure the efficacy of Arm 1 - Standard Dose?

"Arm 1 - Standard Dose has been given a rating of 3 due to its Phase 3 trial status, which reveals the existence of data attesting to both safety and efficacy."

Answered by AI

Is it still possible to register for this research opportunity?

"Contrary to expectation, clinicaltrials.gov suggests that this trial is currently not recruiting participants. Initially posted on February 28th 2024 and last edited on September 26th 2023, the study has yet to open its doors for volunteers--yet 691 other studies are actively doing so at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases

2024. "A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06065449.

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