Radiotherapy for patients with minimally symptomatic spinal metastases

Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD Trial)

This study tests whether giving early radiation therapy to patients with mild spinal metastases can help prevent serious bone problems and improve their overall health.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baptist Health South Florida (other)
• Drugs / interventions: radiation
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT05534321 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of prophylactic radiotherapy in patients with asymptomatic or minimally symptomatic spinal metastases to prevent skeletal-related events. It aims to determine the efficacy of early radiation therapy in improving patient outcomes and reducing hospitalizations. The study includes patients with confirmed solid tumors and high-risk bone metastases, focusing on those who do not require opioid treatment. Participants will receive standard systemic therapy alongside the radiotherapy intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically-confirmed solid tumors and high-risk asymptomatic or minimally symptomatic spinal metastases.

Not a fit: Patients with symptomatic spinal metastases requiring opioids or those who have previously received radiotherapy to the treatment site may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the quality of life and survival rates for patients with spinal metastases.

How similar studies have performed: While there have been numerous studies on symptomatic bone lesions, this approach to prophylactic radiotherapy for minimally symptomatic spinal metastases is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.
2. Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:

   1. Bulkiest sites of spinal osseous disease ≥ 2cm,
   2. Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)
   3. Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
   4. Vertebral body compression deformity \> 50%.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
4. Age ≥ 18 years.
5. Able to provide informed consent.
6. Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.

Exclusion Criteria:

1. Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
2. Serious medical co-morbidities precluding RT.
3. Pregnant or lactating women.
4. Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
5. Leptomeningeal disease.
6. Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.

Where this trial is running

Miami, Florida

• Miami Cancer Institute at Baptist Health South Florida — Miami, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Rupesh R Kotecha, MD — Miami Cancer Institute
• Study coordinator: Rupesh R Kotecha, MD

Conditions: Spine Metastases, Radiotherapy, Palliative radiotherapy, High-risk asymptomatic spine metastases, Minimal asymptomatic spine metastases