Glioblastoma Radiotherapy Using IMRT or Proton Beams

Обзор

Radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. As the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. By using proton beams instead of photon beams, it is possible to protect large parts of the brain which are not affected by the tumor more effectively. An initial retrospective matched-pair analysis showed that this theoretical physical benefit is also clinically associated with a reduction in toxicity during therapy and in the first few months thereafter. The aim of the GRIPS study is to prospectively test this clinical benefit in a randomized, open-label Phase III study. Patients are treated in the study using either modern photon radiation techniques (standard arm) or proton beams (experimental arm). The primary endpoint is the cumulative toxicity CTC grade 2 and higher in the first 4 months. Secondary endpoints include overall survival, progression-free survival, quality of life, and neurocognition.

Вмешательства

• Лучевая терапия Proton irradiation
  proton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE)
• Лучевая терапия Photon irradiation
  proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy

Первичные конечные точки

• Cumulative rate of toxicity [Срок оценки: from start of radiotherapy until progress (max. month 4)]

Вторичные конечные точки (8)

• Progression free survival [Срок оценки: 1 year and 2 years]
• Overall survival [Срок оценки: 1 year and 2 years]
• Acute Toxicity [Срок оценки: start of therapy until 6 weeks after end of therapy (end of therapy up to month 4)]
• Late Toxicity [Срок оценки: 6 weeks after end of therapy (end of therapy up to month 4)]
• Quality of life according to EORTC QLQ-C30 [Срок оценки: 1 year and 2 years]
• Quality of life according to EORTC QLQ-BN20 [Срок оценки: 1 year and 2 years]
• Neurocognition [Срок оценки: 1 year and 2 years]
• Measuring number of Lymphocytes count [Срок оценки: end of therapy up to month 4]

Критерии участия

Критерии включения

• histologically confirmed gliomblastoma WHO IV (operated or after biopsy)
• Indication for radiotherapy / radiochemotherapy
• Informed consent
• KI ≥ 60% or ECOG 0/1
• Age ≥ 18 years
• Sufficient effective contraception

Критерии исключения

• Patient is not able to consent
• Previous radiotherapy in the brain or skull base
• Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)
• Contraindication to MRI imaging
• Simultaneous participation in another clinical trial that could influence the outcome of this study or other study

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

Германия · 3 центра

• Universitätsklinikum Heidelberg — Heidelberg
• Universitätsklinikum Gießen und Marburg — Marburg
• Klinikum Stuttgart — Stuttgart

Публикации

• Konig L, Jakel C, von Knebel Doeberitz N, Kieser M, Eberle F, Munter M, Debus J, Herfarth K. Glioblastoma radiotherapy using Intensity modulated Radiotherapy (IMRT) or proton Radiotherapy-GRIPS Trial (Glioblastoma Radiotherapy via IMRT or Proton BeamS): a study protocol for a multicenter, prospective, open-label, randomized, two-arm, phase III study. Radiat Oncol. 2021 Dec 20;16(1):240. doi: 10.11 PMID 34930368

Идентификаторы

NCT: NCT04752280 · GRIPS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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