Post Operative RT for Limited Spine Metastases

Официальное название

Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy

Обзор

To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control.

Вмешательства

• Процедура Spondylectomy
  Patient will be randomized to treated by spondylectomy or debulking surgery. Spondylectomy implied total resection of involved spine; while debulking surgery means partial resection of involved spine.
• Лучевая терапия SBRT
  Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.

Первичные конечные точки

• Local control [Срок оценки: 12 months post surgery]

Вторичные конечные точки (6)

• Overall survival [Срок оценки: 12 months post surgery]
• pain control [Срок оценки: Every 3 months up to 1 year post surgery]
• Quality of life assessment [Срок оценки: Every 3 months up to 1 year post surgery]
• Quality of life assessment [Срок оценки: pre surgery and 1 month after surgery]
• Quality of life assessment [Срок оценки: Every 3 months up to 1 year post surgery]
• Treatment related toxicity [Срок оценки: Every 3 months up to 1 year post surgery]

Критерии участия

Критерии включения

• Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.
• Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not necessary for surgery are allowed.
• A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
• Patients aged at least 20 years old are eligible.
• Life expectancy of ≥ 6 months.
• ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)
• No prior RT to the index spine level(s)
• Women of childbearing potential must practice adequate contraception
• Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.

Критерии исключения

• Patients received prior radiotherapy to the index spine level.
• Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired renal function.
• Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
• Patients who cannot tolerate radiotherapy immobilization.
• Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:

• Uncontrolled active infection requiring intravenous antibiotics at the time of registration
• Transmural myocardial infarction ≤ 6 months prior to registration.
• Life-threatening uncontrolled clinically significant cardiac arrhythmias.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
• Uncontrolled psychiatric disorder.
• Pregnant or breast-feeding women

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT05495399 · 202204039RINA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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