Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease

Launched by BAPTIST HEALTH SOUTH FLORIDA · Sep 6, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring whether giving radiation therapy early on can help patients with spine metastases who have few or no symptoms. Spine metastases occur when cancer spreads to the spine, and while many studies have looked at treating painful bone lesions, there hasn’t been much research on how early treatment can prevent future problems, like fractures or hospital visits, for patients who aren’t in pain. The goal is to see if starting radiation therapy sooner can improve the quality of life and potentially reduce complications for these patients.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of cancer that has spread to more than five sites in their body. They should have high-risk spinal metastases that are not causing severe pain and should be able to provide informed consent. Patients who are pregnant, have had previous radiation to the same area, or have certain other medical conditions may not qualify. Those who participate will receive radiation therapy and will be monitored to see how it affects their health and any future complications. This trial is currently recruiting participants, so it's an opportunity for eligible patients to potentially benefit from early treatment.

Gender

ALL

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.