Active not recruitingPHASE3INTERVENTIONAL

Comparing Radiation Therapy to Usual Treatment for Patients With High-Risk Bone Metastases That Are Not Causing Pain, PREEMPT Trial

This study is for cancer patients who have bone growths that are considered 'high-risk' but are not currently causing pain. High-risk means the growths are in certain important places (like the hip or spine) or are large, making them more likely to cause problems later, such as bone fractures (breaks) or spinal cord issues. The study wants to find out if adding radiation therapy to a patient's usual treatment helps prevent these bone problems more effectively than just sticking with their usual care (which might involve bone-strengthening drugs or just monitoring). Patients will be split into two groups: one gets usual care, and the other gets usual care plus radiation. The goal is to see which approach reduces bone-related complications and improves quality of life.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

NRG Oncology

Enrolment target

280

Start

07 May 2025

Estimated completion

01 Feb 2029

Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Solid Neoplasm

What is this study about?

Imagine you have cancer, and it has spread to your bones, but these bone areas aren't hurting yet. Some of these bone growths are considered 'high-risk' because of their size or where they are located – this means they might be more likely to cause future problems like bone breaks or pressure on your spinal cord. Doctors want to know the best way to prevent these problems from happening.

This study is looking at two main approaches. One group of patients will receive their 'usual treatment' – which could involve medicines to strengthen bones, treatment for their main cancer, or simply watching the growths closely. The other group will receive their 'usual treatment' plus radiation therapy. Radiation therapy uses strong X-rays to target and shrink cancer cells. It can be given in a single session or a few shorter sessions over several days. The main idea is to see if adding radiation therapy specifically to these high-risk, non-painful bone growths can stop future serious bone complications better than usual care alone.

The researchers will compare what happens in both groups, looking at things like how many bone breaks occur, whether anyone needs surgery for bone issues, how much pain people experience, and their overall quality of life. By doing this, they hope to find out if using radiation early on can improve outcomes for patients with these specific types of bone growths.

Key takeaways

This study compares adding radiation therapy to usual care for non-painful, high-risk bone growths.
It aims to prevent future problems like bone breaks or spinal cord pressure.
Patients are randomly assigned to either usual care or usual care plus radiation.
Eligibility is for adults with solid cancers and specific types of bone growths that aren't causing pain.
Participation involves regular check-ups and potentially radiation treatment.
The study helps provide valuable information for future cancer patient care.

Who may be eligible?

To join this study, you generally need to be an adult (18 years or older) with cancer that has spread to more than five places in your body (not including your brain). You must have some bone growths that are considered 'high-risk' but are not currently causing you pain. High-risk means these growths are either 2 cm or larger, or they are located in specific areas like your hip, shoulder, or certain parts of your spine or long bones.

The bone growths must not be causing pain, meaning your pain score in these areas must be very low (less than 5 out of 10). You also need to have had recent scans (like a CT or PET scan) that show your cancer has spread to your bones.

This study is for people with most types of solid cancers (meaning not blood cancers like myeloma or lymphoma). If you've had treatment for brain growths in the past, you might still be able to join. The study is open to both men and women from all backgrounds.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a solid cancer (not a blood cancer)?
Has your cancer spread to more than 5 places in your body (excluding your brain)?
Do you have bone growths that are 'high-risk' (large or in specific areas like your hip or spine)?
Are these 'high-risk' bone growths currently NOT causing you pain (pain score less than 5 out of 10)?
Have you recently had scans (like CT or PET) that show these bone growths?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups, like flipping a coin. You won't get to choose which group you're in. One group will continue with your doctor's usual care, which might include specific medicines or just close monitoring. The other group will also receive this usual care, but they will additionally get radiation therapy to the high-risk bone growths.

Taking part will involve regular visits to the clinic for assessments, which might include answering health questionnaires, having physical exams, and possibly providing blood samples. If you receive radiation, this will involve several appointments. The study will track your health over time to see how you're doing, looking at things like hospital stays and your overall well-being. The total length of your involvement will depend on your individual treatment plan and follow-up schedule.

Potential risks and benefits

Participating in this study might offer the benefit of potentially preventing serious bone complications like fractures or spinal cord issues if radiation therapy proves to be effective. It also helps contribute to medical knowledge that could benefit future patients. However, there are potential risks, especially with radiation therapy, which can cause side effects like tiredness, skin changes, or temporary discomfort in the treated area. There's also the chance that the radiation might not prevent problems, or your condition could worsen. Remember, you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (627)

Fairbanks Memorial Hospital
Verified postcode
Fairbanks, United States
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
Cancer Center at Saint Joseph's
Verified postcode
Phoenix, United States
Banner-University Medical Center Phoenix
Verified postcode
Phoenix, United States
Banner University Medical Center - Tucson
Verified postcode
Tucson, United States
University of Arizona Cancer Center-North Campus
Verified postcode
Tucson, United States
Kaiser Permanente-Anaheim
Verified postcode
Anaheim, United States
Kaiser Permanente-Deer Valley Medical Center
Verified postcode
Antioch, United States
Mission Hope Medical Oncology - Arroyo Grande
Verified postcode
Arroyo Grande, United States
Sutter Auburn Faith Hospital
Verified postcode
Auburn, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Verified postcode
Auburn, United States
AIS Cancer Center at San Joaquin Community Hospital
Verified postcode
Bakersfield, United States

Common questions

What kind of cancer patients can join?

Patients with solid cancers that have spread to more than five places in their body, excluding brain metastases (unless already treated).

What does 'high-risk bone growths' mean?

It means the cancer in your bones is either large (2 cm or more) or in a vulnerable spot like your hip, spine, or long bones, making it more likely to cause problems later.

Will I feel pain if I join?

The study is specifically for bone growths that are NOT currently causing pain. If you have pain, you likely wouldn't qualify for this specific study arm.

What is 'usual treatment'?

This could include medicines to strengthen bones, treatments for your main cancer, or simply monitoring your condition closely.

Can I choose not to have radiation if I'm in that group?

If you are assigned to the radiation group, having the radiation is part of the study. However, you are always free to withdraw from the study at any time.