Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial

Официальное название

Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study

Обзор

This phase I trial finds out the possible benefits and/or side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.

Подробное описание

PRIMARY OBJECTIVE:

I. To evaluate the feasibility, safety and maximum tolerated dose (MTD) of preoperative radiosurgery in the treatment of patients with biopsy-proven high-grade glioma prior to conventional therapy.

SECONDARY OBJECTIVES:

I. Acute clinical toxicity profile using Common Terminology Criteria for Adverse Events (CTCAE) version 5 (defined as within 4 weeks of completion of postoperative radiotherapy.

II. Radiographic tumor control at 12 months following surgery (per Response Assessment in Neuro-Oncology \[RANO\] criteria).

III. Rate of pseudoprogression at first post radiation scan (RANO criteria). IV. Overall survival at 12 months following surgery.

CORRELATIVE RESEARCH OBJECTIVE:

I. Evaluation of the tumor repair pathways triggered by radiation, tumor vascular changes, tumor microenvironment immune profiling, cell cultures, and the creation of orthotopic xenograft models for future study.

OUTLINE: This is a dose-escalation study.

Patients undergo magnetic resonance imaging (MRI)-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without tumor treating fields (TTF) at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.

After completion of study treatment, patients are followed up every 2-3 months for 12 months and then every 3 months for up to 3 years after registration.

Вмешательства

• Лучевая терапия Radiation Therapy
  Undergo radiation therapy
• Лучевая терапия Radiosurgery
  Undergo radiosurgery
• Процедура Stereotactic Biopsy
  Undergo MRI-guided stereotactic biopsy
• Препарат Temozolomide
  Drug
• Процедура Tumor Treating Fields Therapy
  Undergo TTF
• Процедура Magnetic Resonance Imaging
  Undergo MRI
• Процедура Biospecimen Collection
  Undergo blood sample collection
• Процедура Biopsy
  Undergo biopsy
• Процедура Therapeutic Conventional Surgery
  Undergo surgery

Первичные конечные точки

• Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event [Срок оценки: Up to 4 weeks postoperative radiotherapy]
• Acute clinical toxicity [Срок оценки: Up to 4 weeks postoperative radiotherapy]
• Maximum tolerated dose (MTD) of preoperative radiosurgery [Срок оценки: Up to 4 weeks postoperative radiotherapy]

Вторичные конечные точки (3)

• Radiographic tumor control [Срок оценки: At 12 months post-surgery]
• Rate of pseudoprogression [Срок оценки: At first post radiation scan]
• Overall survival [Срок оценки: At 12 months post-surgery]

Критерии участия

Критерии включения

• Age >= 18 years
• Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged by the Mayo multidisciplinary neuro-oncology team (World Health Organization \[WHO\] grade III-IV, including glioblastoma) regardless of IDH and MGMT status
• Patients who underwent a previous biopsy confirming high grade glioma are eligible for enrollment
• Planned neurosurgical resection of tumor
• Judged to not be at risk of significant clinical risk (i.e. herniation) with radiation-induced edema prior to resection
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
• Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only. Patients over 50 years of age who decline pregnancy testing are still eligible without a pregnancy test.
• Ability to complete questionnaire(s) by themselves or with assistance
• Provide written informed consent
• Willing to receive adjuvant radiotherapy at enrolling institution at the time of registration
• Willing to provide tissue and/or blood samples for correlative research purposes

Критерии исключения

• Any of the following:

• Pregnant women
• Nursing women who are unwilling to cease during therapy
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Prior history of cranial radiotherapy
• Unwillingness to participate in study
• Investigator discretion that enrollment on the study would pose undo harm or risk to the patient
• Non-MRI compatible implanted medical device
• Use of systemic anti-cancer therapy within the previous 3 months
• Medical contraindication to craniotomy and tumor resection
• Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor

• Note: Patients with a history of grade I-II glioma are eligible if they have only received surgery as treatment and now there is concern for transformation to grade III-IV tumor
• Primary spinal cord glioma or primary brainstem glioma
• Residual tumor of excessive volume or eloquent location per investigator discretion
• Patients who are unwilling or unable to comply with study procedures

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Mayo Clinic in Arizona — Phoenix
• Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT05030298 · MC210710 · 20-013209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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