Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease

Trial Title: Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease

NCT ID: NCT05534321

Condition: Spine Metastases

Conditions: Official terms:
Neoplasm Metastasis
Spinal Diseases

Conditions: Keywords:
Radiotherapy (RT)
Palliative radiotherapy
High-risk asymptomatic spine metastases
Minimal asymptomatic spine metastases

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Prophylactic Radiotherapy
Description: Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, three-dimensional conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), and stereotactic radiosurgery/stereotactic body radiation therapy (SRS/SBRT) techniques may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
Arm group label: Prophylactic Radiation Therapy

Intervention type: Drug
Intervention name: Standard of care systemic therapy
Description: Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
Arm group label: Standard of Care Systemic Therapy or Surveillance

Summary: 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Miami Cancer Institute at Baptist Health South Florida

Address:
City: Miami
Zip: 33176
Country: United States

Status: Recruiting

Contact:
Last name: Rupesh Kotecha, MD

Phone: 786-596-2000
Email: RupeshK@baptisthealth.net

Contact backup:
Last name: Antoinette Pimental

Phone: (786) 596-2000
Email: antoinette.pimentel@baptisthealth.net

Investigator:
Last name: Rupesh Kotecha, MD
Email: Principal Investigator

Start date: August 29, 2022

Completion date: September 2027

Lead sponsor:
Agency: Baptist Health South Florida
Agency class: Other

Source: Baptist Health South Florida

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05534321