Radiotherapy for patients with minimally symptomatic spinal metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Baptist Health Herbert Wertheim Cancer Institute
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Rupesh R Kotecha, MD — Baptist Health Herbert Wertheim Cancer Institute
• Study coordinator: Rupesh R Kotecha, MD
• Email: rupeshk@baptisthealth.net
• Phone: (786) 596-2000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.