RECRUITING

Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD Trial)

Quick Facts

Study Start:2022-08-29
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05534321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.
  2. 2. Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:
  3. 1. Bulkiest sites of spinal osseous disease ≥ 2cm,
  4. 2. Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)
  5. 3. Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
  6. 4. Vertebral body compression deformity \> 50%.
  7. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
  8. 4. Age ≥ 18 years.
  9. 5. Able to provide informed consent.
  10. 6. Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.
  1. 1. Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
  2. 2. Serious medical co-morbidities precluding RT.
  3. 3. Pregnant or lactating women.
  4. 4. Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
  5. 5. Leptomeningeal disease.
  6. 6. Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.

Contacts and Locations

Study Contact

Rupesh R Kotecha, MD
CONTACT
17865962000
rupeshk@baptisthealth.net
Antoinette Pimental
CONTACT
17865962000
antoinette.pimentel@baptisthealth.net

Principal Investigator

Rupesh R Kotecha, MD
PRINCIPAL_INVESTIGATOR
Miami Cancer Institute

Study Locations (Sites)

Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, 33176
United States

Collaborators and Investigators

Sponsor: Baptist Health South Florida

  • Rupesh R Kotecha, MD, PRINCIPAL_INVESTIGATOR, Miami Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-29
Study Completion Date2027-09

Study Record Updates

Study Start Date2022-08-29
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Radiotherapy (RT)
  • Palliative radiotherapy
  • High-risk asymptomatic spine metastases
  • Minimal asymptomatic spine metastases

Additional Relevant MeSH Terms

  • Spine Metastases