Prophylactic Radiotherapy for Spinal Metastases
(PROMISSeD Trial)
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?
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?
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive upfront prophylactic radiotherapy to ≤ 5 highest risk bone metastases followed by standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of skeletal-related events and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Prophylactic Radiotherapy
Prophylactic Radiotherapy is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baptist Health South Florida
Lead Sponsor