Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases

Официальное название

A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for Brain Metastases

Обзор

This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain (brain metastases). SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.

Подробное описание

PRIMARY OBJECTIVE:

I. To investigate the 1 year leptomeningeal disease (LMD)-free rate among patients with surgically resectable metastatic brain lesions randomized to post-operative stereotactic radiosurgery (SRS) (standard care) versus pre-operative SRS followed by surgery (experimental arm).

SECONDARY OBJECTIVE:

I. To investigate the local control (LC), distant brain metastasis rate, overall survival (OS) of pre-operative (pre-op) versus (vs) post-operative (post-op) SRS in patients with brain metastasis.

EXPLORATORY OBJECTIVES:

I. To assess the reliability of different imaging features by using a combination of patient data and phantom data to quantify the uncertainties associated with using magnetic resonance imaging (MRI) for radiomics studies.

II. To assess the correlation of imaging-pathology correlates using multiparametric imaging that characterize the tumor and peri-tumoral microenvironment including features such as tumor vascular characteristics, cellular density, oxygenation and presence of inflammation/immune reactivity.

III. To investigate the neuro-cognitive impact, patient reported outcomes and health-related quality of life of pre-operative (pre-op) vs post-operative (post-op) SRS in patients with brain metastasis.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (PRE-OPERATIVE SRS): Patients undergo SRS within 15 days of randomization followed by surgery within 15 days. Patients may undergo additional SRS if disease returns after treatment.

GROUP II (POST-OPERATIVE SRS): Patients undergo surgery within 15 days of randomization followed by standard of care SRS within 30 days. Patients may undergo additional SRS if disease returns after treatment.

After completion of study treatment, patients are followed up periodically.

Вмешательства

• Другое Quality-of-Life Assessment
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies
• Лучевая терапия Stereotactic Radiosurgery
  Undergo SRS

Первичные конечные точки

• Leptomeningeal disease (LMD)-free rate [Срок оценки: At 1 year]

Вторичные конечные точки (3)

• Local control rate [Срок оценки: At 1 year]
• Distant brain control [Срок оценки: At 1 year]
• Overall survival (OS) [Срок оценки: At 1 year]

Критерии участия

Критерии включения

• The primary lesion pre-operatively can have a maximum diameter of =< 4 cm for single fraction and =< 7 cm for multifraction therapy
• Patients must be considered candidates for SRS within +/- 30 days of surgical resection as defined by either history and physical (H\&P) or presentation at brain metastasis tumor board conference note
• Patients must have a Karnofsky performance scores >= 70 or Eastern Cooperative Oncology Group (ECOG) >= 2 within 30 days of enrollment
• Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form
• No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center (MDACC) departmental radiology report or study neuro-radiologist review
• Documented history of malignancy

Критерии исключения

• Patients who have received prior radiation therapy to the brain for any reason
• The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma
• For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy)

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

США · 1 центр

• M D Anderson Cancer Center — Houston

Публикации

• Yeboa DN, Li J, Lin R, Prabhu SS, Beckham TH, Woodhouse K, Swanson TA, Weinberg JS, Wang X, Chi X, Ejezie CL, Suki D, Wang C, Ene C, McCutcheon IE, McGovern S, McAleer MF, Tom M, Ghia A, Perni S, Jiang W, De B, Chung C, Kim BYS, O'Brien BJ, Huse JT, Wefel JS, Court L, Tawbi H, Janku F, Guha-Thakurta N, Debnam JM, Johnson J, Taslicay CA, Alvarez-Breckenridge C, Raza SM, Heimberger AB, DeMonte F, No PMID 40531511

Идентификаторы

NCT: NCT03741673 · 2018-0552 · NCI-2018-02220 · 2018-0552

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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