Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

Обзор

This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

Подробное описание

PRIMARY OBJECTIVES:

I. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I)

II. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)

SECONDARY OBJECTIVES:

I. To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection.

II. To estimate the rate of salvage surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) for participants treated with neoadjuvant radiosurgery followed by surgical resection.

III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.

OUTLINE: This is a phase I, dose-escalation study of radiosurgery followed by a phase II study.

The following outcomes were removed from the protocol in an amendment:

* Changes in neurocognitive function as measured by the Hopkins Verbal Learning Test (HVLT), Controlled Oral Word Association (COWA) \& Trailmaking Test B, and Trailmaking Test A * QOL measured by FACT-BR and EORTC-QLQ30

Вмешательства

• Лучевая терапия radiosurgery
  Undergo radiosurgery
• Процедура therapeutic conventional surgery
  Undergo surgical resection
• Процедура quality-of-life assessment
  Ancillary studies

Первичные конечные точки

• Maximum tolerated dose (MTD) [Срок оценки: Day 0]
• Proportion of participants without local failure (Phase II) [Срок оценки: Up to 3 years]

Вторичные конечные точки (3)

• Proportion of participants with distant brain failure [Срок оценки: Up to 3 years]
• Rate of radiation necrosis/steroid dependency [Срок оценки: Up to 3 years]
• Rate of salvage treatment [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
• Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion > 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
• Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
• Patient must have a Karnofsky performance score of ≥ 70

Критерии исключения

• Patient deemed medically unfit to undergo surgical resection of brain metastasis
• Prior whole brain radiotherapy
• Patient with contraindication for imaging with MRI
• Inability to participate in study activities due to physical or mental limitations
• Inability or unwillingness to return for all the required follow-up visits
• At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
• Tumor located in the brainstem
• Imaging or cytologic evidence of leptomeningeal disease

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 · 2 центра

• University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland
• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland

Идентификаторы

NCT: NCT01891318 · CASE7312

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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