Miami "RADAR" Trial

Официальное название

The Miami "RADAR" Trial - RAdiosurgical Debulking of Asymptomatic/Radiographic Spinal Cord Compression

Обзор

The purpose of this study is to see if treating cancer with radiation therapy administered by the Varian Ethos system can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).

Вмешательства

• Лучевая терапия Stereotactic Radiosurgery (SRS)
  The treatment regimen consists of 8.0 Gy of radiation therapy administered on the Varian Ethos platform, delivered over five (5) fractions prescribed to the planning target volume (PTV) over 4 weeks, with one (1) to two (2) fractions delivered weekly and at least 48 hours between any two fractions.

Первичные конечные точки

• Rate of Safe Avoidance of Surgery [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Investigator Confidence in Ethos Virtual Magnetic Resonance (MR) Workflow [Срок оценки: Day 1 of Treatment, Up to 4 weeks]
• Rate of Radiation Myelopathy (RM) [Срок оценки: Baseline, Up to 8 months]
• Rate of Vertebral Compression Fracture (VCF) [Срок оценки: Up to 2 years]
• Number of Participants Experiencing Grade 2 or Higher Treatment-Related Adverse Events [Срок оценки: Up to 12 months]
• Quality of Life Among Study As Measured by Scores on PROMIS Short Form Version 1.0 [Срок оценки: Baseline, Up to 6 months]
• Rate of Ambulation Preservation [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Male and female participants ages ≥ 18.
• Solid tumors causing Metastatic epidural spinal cord compression (MESCC) for which surgery is an option as first-line treatment.
• Tumor histologies eligible for treatment include breast, prostate, sarcoma, melanoma, gastrointestinal types, NSCLC and renal cancers. Other solid malignancy types are also allowed at discretion of investigator if not specifically excluded by criteria.
• MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement.
• Bilsky scale ≥ 1c MESCC with tumor ≤ 1 mm from the spinal cord or cauda equina nerve roots anywhere from C1 to terminus of cauda equina on screening MRI.
• Protocol defined MESCC must involve no more than 3 contiguous vertebral levels. MESCC can involve multiple non-contiguous spinal canal regions within those 3 contiguous vertebral levels.
• Karnofsky performance score ≥60
• Survival prognosis ≥3 months
• Medical status allowing surgery.
• Neurologic exam within 1 week prior to registration and again within 1 week of first treatment to rule out severe neurologic deficits caused by disease at site of cord compression.
• Patients with mild to moderate cord neurologic signs are eligible if they are improved or stabilized by steroid. These neurologic signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function).
• All patients must be ambulatory.
• Numerical Rating Pain Scale within 1 week prior to registration (back pain permitted for enrollment).
• Spine instability neoplastic score < 14.

a. An exception to this criterion may be made if the patient is evaluated by a spinal surgeon and the surgeon defers surgery.

• Willing and able to undergo daily MRI during treatment.
• Willingness and able to use an acceptable method of contraception during the study and for at least 6 months after stopping the therapy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• History and physical within 2 weeks prior to registration.
• Patients must provide study specific informed consent prior to study entry.

Критерии исключения

• Unknown primary histology.
• Patients with rapid neurologic decline.
• Bony retropulsion causing neurologic abnormality.
• Non-ambulatory patients.
• Prior radiation to the involved site.
• Inability to have an MRI.
• Pre-existing or concomitant neurological problems not related directly to MESCC (e. g., neurologic deficits due to brain metastases).
• Very radiosensitive tumor histology (e.g., myeloma, seminoma, germ cell tumors, leukemia, and lymphoma).
• Patients with impaired decision-making capacity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT06077071 · 20221377

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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