124 Participants Needed

High-Dose Radiation for Bone Metastases Pain

Recruiting at 6 trial locations
Matthew P Deek, MD profile photo
Salma Jabbour, MD profile photo
Overseen BySalma Jabbour, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether higher doses of external beam radiation can better relieve pain from cancer that has spread to the bones. The goal is to determine if more intense radiation in specific amounts can help more people experience less pain for a longer duration. The trial includes different groups; one receives the higher radiation dose, while the other follows standard procedures. Individuals with cancer that has spread to their bones and who experience significant pain might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially experience improved pain relief.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that external beam radiation effectively reduces pain from cancer that has spread to the bones. Studies have found that most patients tolerate it well. However, not everyone experiences complete pain relief, and for some, the pain may return within a year. Evidence suggests that a higher dose of radiation could enhance pain relief. This trial tests a higher dose than usual, which might prove more effective.

While this treatment is commonly used, side effects such as skin irritation or fatigue can occur, though serious issues are rare. This type of radiation is already widely used for similar conditions, supporting its safety. The trial aims to determine whether higher doses can provide better pain relief without causing excessive side effects.12345

Why are researchers excited about this trial's treatment?

Unlike the standard of care for bone metastases pain, which typically involves lower doses of radiation, this new protocol explores higher doses of external beam radiation to potentially deliver more effective pain relief. Researchers are excited about this approach because it aims to escalate the radiation dose in a controlled way, possibly enhancing pain management while maintaining safety by adapting the number of fractions. Additionally, for those experiencing benefits but also toxicity, the protocol allows for ongoing treatment with careful monitoring, offering a personalized touch that could improve patient outcomes.

What evidence suggests that high-dose radiation is effective for pain relief in bone metastases?

Research has shown that external beam radiation therapy effectively reduces pain from cancer that has spread to the bones. Studies have found that about 70% of patients with painful bone metastases experience some or complete relief after this treatment. A review of several studies found pain relief rates between 72% and 75% with standard radiation treatments. In this trial, one arm tests higher doses of radiation to determine if they can provide better and longer-lasting pain relief compared to standard doses.12467

Who Is on the Research Team?

MP

Matthew P Deek, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

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.

Inclusion 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.
Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
See 7 more

Exclusion Criteria

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.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive dose escalated radiation therapy for pain management in non-spinal bone and non-bone metastases

2 weeks
10 visits (in-person)

Follow-up

Participants are monitored for pain response, quality of life, and adverse events

4 weeks
1 visit (in-person), 1 visit (virtual)

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness of the treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • EXTERNAL BEAM RADIATION

Trial Overview

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.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Palliative radiation dose escalationExperimental Treatment1 Intervention
Group II: Therapeutic benefitActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

Citations

External Beam Radiation Therapy for Palliation of ...

External beam radiation therapy (RT) is a particularly effective modality for managing bone metastases, with evidence supporting its efficacy ...

Palliative Radiation Therapy For Bone Metastases - NCBI - NIH

Up to 40% of patients do not obtain pain relief after initial therapy, and pain relapse is seen in 50% within 1 year of treatment.[34] No ...

Pain response of patients treated with radiotherapy for ...

Approximately 70% of patients with painful bone metastases experience a partial or complete pain response after radiotherapy. Over the past decade, the pain ...

Pain Response Rates After Conventional Radiation ...

Previous meta-analysis of conventional radiation therapy for painful bone metastases showed overall response (OR) rates of 72% to 75% ( ...

Re-treatment of bone metastases for pain control

Notably, studies have indicated that dose escalation beyond 24 Gy in 2 fractions may enhance this benefit (17,18).

External Beam Radiation Therapy for Palliation of ...

Symptomatic bone metastases treated with conventional RT are recommended 800 cGy in 1 fraction (800 cGy/1 fx), 2000 cGy/5 fx, 2400 cGy/6 fx, or 3000 cGy/10 fx.

Bone Metastases Guideline

Clinical Outcomes of Dose-Escalated Hypofractionated External Beam. 942. Radiation Therapy (5 Gy × 5 Fractions) for Spine Metastasis. Advances ...