← Back to Search

Radiation

High-Dose Radiation for Bone Metastases Pain

Phase 2

Recruiting

Led By Matthew P Deek, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologic proof of malignancy

A female participant is eligible to participate if she is not pregnant and not breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month

Awards & highlights

Study Summary

This trial is investigating whether a higher dose of radiation will result in more complete pain responses in patients with non-spinal bone metastases.

Who is the study for?

This trial is for adults with cancer who have painful bone or non-bone metastases, not including the spine. They must be able to consent, follow contraceptive guidance if of childbearing potential, have a life expectancy of six months or more, and manage a pain score of at least 3. Those with highly radiosensitive tumors, spinal metastasis, previous radiation to the same site or needing treatment in more than three sites are excluded.Check my eligibility

What is being tested?

The study tests whether increasing the radiation dose to 40-50 Gy in ten sessions can improve and prolong pain relief for patients with painful bone (excluding spine) and non-bone metastases from various cancers. The goal is to see if higher doses lead to better outcomes one month after treatment.See study design

What are the potential side effects?

Potential side effects include skin reactions at the treatment site, fatigue due to radiation exposure, possible temporary increase in pain before improvement ('pain flare'), nausea or vomiting depending on area treated.

Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer diagnosis was confirmed through tissue examination.

Select...

I am not pregnant and not breastfeeding.

Select...

My cancer has spread to my bones or other parts of my body.

Select...

I need considerable assistance and am unable to do any work.

Select...

My pain level is 3 or higher on a scale of 0-10.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month

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

Treatment Details

Study Objectives

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

Primary outcome measures

Safety as assessed by number of participants experiencing adverse events

Secondary outcome measures

Severity as assessed by number of participants experiencing toxicity and adverse events

Other outcome measures

Pain as assessed by number of participants experiencing pain response

Quality-of-life (QOL) as assessed by the Brief Pain Inventory (BPI). Using the 16 item scale

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Palliative radiation dose escalationExperimental Treatment1 Intervention

The prescribed dose is 50 Gy in 10 fractions. The total dose can be reduced to 40 Gy and the total number of fractions can be reduced to 8 fractions in non-spine metastases to achieve the normal tissue constraints.

Group II: Therapeutic benefitActive Control1 Intervention

Radiation will be delivered as per protocol. For participants experiencing unacceptable toxicity related to study treatment, yet obtaining therapeutic benefit, participants will be allowed to continue treatment, if well tolerated at the discretion of the investigator.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,108 Total Patients Enrolled

Matthew P Deek, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Media Library

EXTERNAL BEAM RADIATION (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05419518 — Phase 2

Cancer Research Study Groups: Palliative radiation dose escalation, Therapeutic benefit

Cancer Clinical Trial 2023: EXTERNAL BEAM RADIATION Highlights & Side Effects. Trial Name: NCT05419518 — Phase 2

EXTERNAL BEAM RADIATION (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05419518 — Phase 2

Frequently Asked Questions

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

Are there any slots remaining in this trial?

"The clinicaltrials.gov website reveals that this particular trial is no longer taking on patients, though it was initially posted July 30th 2022 and subsequently edited June 10th 2022. Fortunately, there are 2922 other studies actively recruiting volunteers at the moment."

Answered by AI

Has the FDA sanctioned EXTERNAL BEAM RADIATION for clinical use?

"While there is evidence confirming the safety of external beam radiation, it has not been fully backed by efficacy findings. Consequently, our team at Power assigned a rating of 2 to this treatment option."

Answered by AI

Is there a significant presence of this trial in Canadian healthcare facilities?

"At this time, there are 5 institutions participating in the clinical trial; RWJBarnabas Health - Robert Wood Johnson University Hospital (Hamilton), Cancer Institute of New jersey (Somerset), and RWJBarnabas Health - Saint Barnabas Medical Center (Livingston) along with an additional five sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas

Matthew Pierre Deek 2023. "Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05419518.