Radiotherapy in IDH Mutated Glioma: Evaluation of Late Outcomes
Кључне речи
Апстрактан
Датуми
Последња верификација: | 02/29/2020 |
Фирст Субмиттед: | 03/08/2020 |
Предвиђена пријава послата: | 03/08/2020 |
Прво објављено: | 03/10/2020 |
Послато последње ажурирање: | 03/22/2020 |
Последње ажурирање објављено: | 03/24/2020 |
Стварни датум почетка студије: | 12/09/2019 |
Процењени датум примарног завршетка: | 04/30/2024 |
Предвиђени датум завршетка студије: | 04/30/2026 |
Стање или болест
Фаза
Групе руку
Арм | Интервенција / лечење |
---|---|
Study group Glioma, IDH mutated, grade 2 and 3 |
Критеријуми
Узраст подобан за студирање | 18 Years До 18 Years |
Полови подобни за студирање | All |
Метода узорковања | Non-Probability Sample |
Прихвата здраве волонтере | да |
Критеријуми | Inclusion Criteria: - Histologically confirmed glioma, World Health Organisation (WHO) grade 2 or 3, IDH mutated - Indication for standard treatment with radiotherapy and chemotherapy. For WHO grade 2 tumors 50.4 Gy relative biological equivalent (RBE) in 28 fractions. For WHO grade 3 tumors 59.4 Gy (RBE) in 33 fractions. - Ability to comply with the protocol, including neuropsychological testing and imaging. - Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician. - Written informed consent. Exclusion Criteria: - Any prior chemotherapy for IDHmG. This includes upfront postoperative chemotherapy. - Any prior cranial radiotherapy, including but not limited to radiotherapy for IDHmG. - Prior invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with current prostate specific antigen (PSA) of less than or equal to 0.1 ng/mL). - Extensive white matter disease visible on pre-therapy imaging (Fazekas grade ≥2) - Contra-indication for magnetic resonance (MR) imaging (i.e. metal implants, claustrophobia) - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule in the participating hospitals - Any other serious medical condition that could interfere with follow-up. - Severe aphasia or language barrier interfering with assessing endpoints (i.e. completion of questionnaires or neurocognitive performance) |
Исход
Примарне мере исхода
1. Toxicity (selected CTCAE 5.0 items) [24 months]
2. Neurocognitive testing [24 months]
Секундарне мере исхода
1. Next intervention free survival (NIFS) [48 months]
2. Progression Free Survival (PFS) [48 months]
3. Overall Survival (OS) [48 months]
4. Health Related Quality of Life (HRQOL) [24 months]
5. Health - Related Economics [24 months]
Остале мере исхода
1. Radiological data [4 months]