74 Participants Needed

Prophylactic Radiotherapy for Spinal Metastases

(PROMISSeD Trial)

RR
MC
AP
Overseen ByAntoinette Pimental
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Baptist Health South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.

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 prophylactic radiotherapy for spinal metastases safe for humans?

Radiotherapy, including prophylactic radiotherapy, is generally considered safe for humans, with mostly mild side effects. However, it can cause nausea and affect blood cell counts, so monitoring is important, especially when large areas are treated.12345

How is prophylactic radiotherapy different from other treatments for spinal metastases?

Prophylactic radiotherapy is unique because it is used early to prevent complications like pain and fractures in patients with spinal metastases, rather than just treating symptoms after they occur. This approach aims to maintain quality of life by addressing potential issues before they become problematic.678910

What data supports the effectiveness of the treatment Prophylactic Radiotherapy for Spinal Metastases?

Research shows that radiotherapy for spinal metastases can provide pain relief and improve quality of life, with response rates of up to 60-80% in reducing symptoms like pain and preventing complications such as fractures.6781011

Who Is on the Research Team?

Rupesh Rajesh Kotecha, MD - Baptist ...

Rupesh R Kotecha, MD

Principal Investigator

Miami Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with solid tumor malignancy and multiple spinal metastases that are minimally symptomatic. They should have a good performance status, not be pregnant or breastfeeding, and agree to use contraception. It's not for those who've had prior radiation at the treatment site, have serious health issues preventing RT, or where joining would delay their care.

Inclusion Criteria

My cancer has spread to more than 5 different areas.

Exclusion Criteria

Patients whose entry to the trial will cause unacceptable clinical delays in their planned management
I've had radiation therapy before where we now want to treat, and can't have more without risking harm to healthy tissues.
My cancer has spread to my bones, risking spinal damage or bone breakage.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive upfront prophylactic radiotherapy to ≤ 5 highest risk bone metastases followed by standard of care

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of skeletal-related events and quality of life

12 months
Assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Prophylactic Radiotherapy
Trial Overview The study tests if early radiotherapy (RT) on asymptomatic or slightly symptomatic spinal metastases can prevent skeletal-related events better than standard systemic therapy alone. The goal is to see if this upfront RT reduces hospitalizations and complications from these bone lesions.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Prophylactic Radiation TherapyExperimental Treatment1 Intervention
Group II: Standard of Care Systemic Therapy or SurveillanceActive Control1 Intervention

Prophylactic Radiotherapy is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Prophylactic Radiotherapy for:
🇺🇸
Approved in United States as Prophylactic Radiotherapy for:
🇨🇦
Approved in Canada as Prophylactic Radiotherapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials
54
Recruited
8,100+

Published Research Related to This Trial

In a study of 342 patients with painful spinal metastases, 73% responded positively to radiotherapy, which is shown to be a safe and effective noninvasive treatment for pain management.
The median overall survival for these patients was 7 months, with a new scoring system developed to predict survival based on factors like performance status and the presence of visceral metastases, helping guide treatment decisions.
Prediction of survival in patients with metastases in the spinal column: results based on a randomized trial of radiotherapy.van der Linden, YM., Dijkstra, SP., Vonk, EJ., et al.[2022]
Dose-escalated radiotherapy (RT) for spinal metastases and paraspinal tumors showed an impressive local control rate of 88% after 2 years, with only one local recurrence observed among 14 patients treated.
The treatment was safe, with only mild to moderate acute skin toxicity in 2 patients and no cases of radiation-induced myelopathy, indicating that this approach can effectively manage pain and control tumor growth without significant long-term side effects.
Clinical outcome of dose-escalated image-guided radiotherapy for spinal metastases.Guckenberger, M., Goebel, J., Wilbert, J., et al.[2022]
Patients with spinal metastases often felt inadequately informed about the expected outcomes of their treatment, despite being well-informed about procedures and complications.
Most patients' expectations for pain relief and improved daily functioning were only partially met after treatment, highlighting the need for better communication between patients and healthcare providers to set realistic treatment expectations.
Patient Expectations About Palliative Treatment for Symptomatic Spinal Metastases: A Qualitative Study.Gal, R., Charest-Morin, R., Verlaan, JJ., et al.[2023]

Citations

Prediction of survival in patients with metastases in the spinal column: results based on a randomized trial of radiotherapy. [2022]
Clinical outcome of dose-escalated image-guided radiotherapy for spinal metastases. [2022]
Patient Expectations About Palliative Treatment for Symptomatic Spinal Metastases: A Qualitative Study. [2023]
Radiation therapy of spinal metastases: results with different fractionations. [2022]
[Palliative Radiotherapy - An Important Tool in the Event Of Painful Bone Metastases]. [2021]
Palliative radiotherapy--new approaches. [2022]
Diabetes increases the risk of serious adverse events after re-irradiation of the spine. [2020]
Radiotherapy of Bone Metastasis in Breast Cancer Patients - Current Approaches. [2022]
Skeletal metastases. [2019]
Palliative radiotherapy: past, present and future-where do we go from here? [2019]
The role of external beam radiotherapy in the management of bone metastases. [2022]
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