GlioCave

The purpose of the trial is to compare an adjuvant fractionated stereotactic radiotherapy to the resection cavity after complete resection of a recurrent glioblastoma to observation after this surgery. The aim of the study is to compare progression free survival as a primary endpoint, and overall survival, toxicity and safety as secondary endpoints. Focus of the analysis is to evaluate the change in progression free survival by fractionated stereotactic radiotherapy to the resection cavity. Therefore, the aim of the trial is to evaluate the improvement in outcome due to glioma cell reduction by radiotherapy around the resection cavity. No systemic therapy is part of the protocol. If deemed to be advantageous, systemic therapy or Tumor Treatment Fields (TTFields) can be prescribed regardless to the treatment arm at best investigators choice. Concurrent systemic therapy is not an exclusion criteria for this study.

{ "short_title": "GlioCave", "data_mode": "900", "data_mode_number": "000001136", "official_title": "Adjuvant stereotactic fractionated radiotherapy to the resection cavity in recurrent glioblastoma", "accrual_state": "stoppedTemporarily", "therapeutic_value": "therapeutic", "therapieansatz_value": null, "therapieintervention_value": null, "therapielinie_value": null, "ctgov_number": "NCT02715297", "eudract_number": null, "general_contact_email": "str.studien@uniklinikum-dresden.de", "general_contact_phone": "+49 351-4582238", "hauptpruefer_dd_name": "Prof Dr. med. Mechthild Krause", "description_laie_de": null, "description_laie_en": null, "description_expert_de": null, "description_expert_en": "The purpose of the trial is to compare an adjuvant fractionated stereotactic radiotherapy to the resection cavity after complete resection of a recurrent glioblastoma to observation after this surgery. The aim of the study is to compare progression free survival as a primary endpoint, and overall survival, toxicity and safety as secondary endpoints. Focus of the analysis is to evaluate the change in progression free survival by fractionated stereotactic radiotherapy to the resection cavity. \r\nTherefore, the aim of the trial is to evaluate the improvement in outcome due to glioma cell reduction by radiotherapy around the resection cavity. No systemic therapy is part of the protocol. If deemed to be advantageous, systemic therapy or Tumor Treatment Fields (TTFields) can be prescribed regardless to the treatment arm at best investigators choice. Concurrent systemic therapy is not an exclusion criteria for this study.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 8, "sub_cat_id": 42 }