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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 belowSelect...
My cancer diagnosis was confirmed through tissue examination.
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I am not pregnant and not breastfeeding.
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My cancer has spread to my bones or other parts of my body.
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I need considerable assistance and am unable to do any work.
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My pain level is 3 or higher on a scale of 0-10.
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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
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.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
430 Previous Clinical Trials
64,534 Total Patients Enrolled
Matthew P Deek, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer diagnosis was confirmed through tissue examination.The study is only for people who are expected to live for at least six more months.I am not pregnant and not breastfeeding.My cancer has spread to my bones or other parts of my body.I need considerable assistance and am unable to do any work.My pain level is 3 or higher on a scale of 0-10.My cancer has spread to my spine.I have pressure on my spinal cord.My cancer, which spreads easily with radiation, has spread from another part of my body.I need radiation treatment for more than 3 areas.I agree to use contraception for 120 days after my last treatment dose.I am 18 years old or older.I have had radiation therapy to the same area before.
Research Study Groups:
This trial has the following groups:- Group 1: Palliative radiation dose escalation
- Group 2: Therapeutic benefit
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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