NL-OMON28530尚未招募不适用
Radiotherapy in IDH mutated Glioma: Evaluation of Late outcomes
ErasmusMC0 个研究点目标入组 79 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 79
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Age > 18 years
- •- Histologically confirmed glioma, WHO grade 2 or 3, IDH1/2 mutated
- •- Indication for standard treatment with radiotherapy and chemotherapy
- •--- For WHO grade 2 tumors 50.4 Gy (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 con-sent, as determined by the treating physician.
- •- Written informed consent.
排除标准
- •- 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 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 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. comple-tion of questionnaires or neurocognitive performance)
研究者
相似试验
已完成
不适用
Radiotherapy in IDH Mutated Glioma: Evaluation of Late OutcomesAstrocytoma, Grade IIAstrocytoma, Grade IIIOligodendrogliomaOligodendroglioma, AnaplasticNCT04304300Erasmus Medical Center79
已完成
3 期
IDH mutated 1p/19q intact lower grade glioma following resection: Wait Or Treat? IWOT - A phase III studyNL-OMON48284European Organisation for Research in Treatment of Cancer (EORTC)127
进行中（未招募）
1 期
Treatment of IDH mutated, 1p/19q lower malignant grade glioma of the brain after surgery: Wait with further treatment or start Treatment immediately : I-WOTHistologically WHO grade II (diffuse) or III (anaplastic) astrocytoma, IDHmt without 1p/19q co-deletion (local diagnosis)MedDRA version: 20.0Level: PTClassification code 10065869Term: Astrocytoma, low gradeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10002224Term: Anaplastic astrocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003539-31-NOEuropean Organisation for Research and Treatment of Cancer624
进行中（未招募）
1 期
Treatment of IDH mutated, 1p/19q lower malignant grade glioma of the brain after surgery: Wait with further treatment or start Treatment immediately : I-WOTHistologically WHO grade II (diffuse) or III (anaplastic) astrocytoma, IDHmt without 1p/19q co-deletion (local diagnosis)MedDRA version: 20.0Level: PTClassification code 10065869Term: Astrocytoma, low gradeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10002224Term: Anaplastic astrocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003539-31-NLEuropean Organisation for Research and Treatment of Cancer624
进行中（未招募）
1 期
Treatment of IDH mutated, 1p/19q lower malignant grade glioma of the brain after surgery: Wait with further treatment or start Treatment immediately : I-WOTHistologically WHO grade II (diffuse) or III (anaplastic) astrocytoma, IDHmt without 1p/19q co-deletion (local diagnosis)MedDRA version: 21.1Level: PTClassification code 10065869Term: Astrocytoma, low gradeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10002224Term: Anaplastic astrocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003539-31-DKEuropean Organisation for Research and Treatment of Cancer624