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Radiation Therapy
Prophylactic Radiotherapy for Spinal Metastases (PROMISSeD Trial)
Phase 1 & 2
Recruiting
Led By Rupesh R Kotecha, MD
Research Sponsored by Baptist Health South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
PROMISSeD Trial Summary
This trial will help determine whether it is beneficial for patients with minimally symptomatic disease to undergo radiation therapy to reduce the risks of skeletal-related events.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally radiotherapy can cause skin irritation at the treatment site, fatigue, mild swelling due to inflammation around treated bones, and sometimes nausea. Long-term effects might include changes in bone strength.
PROMISSeD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who have skeletal-related events (SREs)
Secondary outcome measures
Adverse event frequency and severity
Health care utilities and quality of life
Number of skeletal-related event (SRE) hospitalizations
+3 morePROMISSeD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prophylactic Radiation TherapyExperimental Treatment1 Intervention
Patients randomized to Arm 2 of the study will undergo upfront prophylactic radiotherapy to ≤ 5 highest risk bone metastases followed by standard of care, as defined by:
Bulkiest sites of disease ≥ 2cm (can include paraspinal disease extension)
Disease in junctional spine (Occ-C2, C7-T1, T12-L1, L5-S1)
Disease with posterior element involvement (facet(s), interspinous)
Compression Deformity > 50%
Group II: Standard of Care Systemic Therapy or SurveillanceActive Control1 Intervention
Patients randomized to arm 1 will undergo appropriate systemic therapy as determined by their oncology team. These patients will either continue the current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to arm 1, these patients may also undergo palliative radiation therapy for progressive or painful lesions (a skeletal related event as defined in the study) at the time of symptom development*(not upfront palliative radiation therapy)
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Who is running the clinical trial?
Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,757 Total Patients Enrolled
Rupesh R Kotecha, MDPrincipal InvestigatorMiami Cancer Institute
2 Previous Clinical Trials
220 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to more than 5 different areas.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.I have serious health issues that prevent me from receiving radiation therapy.My cancer has spread to the lining of my brain and spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Prophylactic Radiation Therapy
- Group 2: Standard of Care Systemic Therapy or Surveillance
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new patients being accepted for this experiment?
"Clinicaltrials.gov has reported that this clinical trial is actively seeking suitable participants, the first post of which was on August 29th 2022 and last revised September 23rd 2022."
Answered by AI
How many individuals are receiving treatment within this experimental protocol?
"Affirmative, according to the information hosted on clinicaltrials.gov this investigation is actively seeking volunteers; it was first posted August 29th 2022 and updated September 23rd 2022. The scientific trial needs 74 individuals from one medical facility."
Answered by AI
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