Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care

Официальное название

Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM)

Обзор

This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows: * A Screening/Baseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B. * A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B). * An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase. * An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg/m2/day orally for each Arm. * An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg/m2/day orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator. * An Early Discontinuation/Follow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days. For any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status.

Вмешательства

• Устройство GammaTile®
  GammaTiles are a U.S. FDA-cleared, surgically targeted radiation therapy for patients with certain brain tumors. GammaTile consists of bioresorbable collagen tiles embedded with Cesium-131 (Cs-131) radioactive seeds
• Лучевая терапия External Beam Radiation Therapy
  External beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body
• Препарат Temozolomide
  TMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor

Первичные конечные точки

• Overall Survival [Срок оценки: Days from surgery to death.]

Вторичные конечные точки (5)

• Progression Free Survival [Срок оценки: Days from surgery to death or disease progression.]
• Time to next unplanned treatment [Срок оценки: Time to next unplanned treatment.]
• Performance Status [Срок оценки: 24 months.]
• Safety Assessment [Срок оценки: Study duration.]
• Quality of Life Assessments [Срок оценки: COST-Score duration of study; FACT-Br up to 12 months after randomization.]

Критерии участия

Major Criteria Includes the Following:

Критерии включения

• Patients must be ≥18 years of age.
• Have radiographic suspicion of newly diagnosed glioblastoma (GBM).

o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and efficacy analyses.

• Are medically and surgically appropriate for resection.
• Have an estimated Karnofsky Performance Scale (KPS) score of ≥70.
• Are able to receive standard of care treatment.

Критерии исключения

• A previous biopsy diagnosis other than IDH wild-type GBM.
• Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography.
• Have multi-focal enhancing tumors that cannot be encompassed in one operative field.

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 · 6 центров

• HonorHealth Scottsdale Osborn Medical Center — Scottsdale
• Jersey Shore University Medical Center | Hackensack — Neptune City
• Westchester Medical Center — Valhalla
• East Carolina University — Greenville
• Allegheny Health Network — Pittsburgh
• Brown University Health — Providence

Идентификаторы

NCT: NCT07195591 · GTM-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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