Randomized phase IIb/III trial of autologous tumor vaccine with temozolomide for newly diagnosed glioblastoma

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2013
INTERVENTION: vaccine non vaccine CONDITION: newly diagnosed glioblastoma PRIMARY OUTCOME: overall survival SECONDARY OUTCOME: 1) Cause‐specific survival ; 2) Progression‐free survival ; 3) Tumor‐regression rate, disease‐control rate ; 4) QOL ; 5) Neurological improvement INCLUSION CRITERIA: 1) 16 to 75 years of age. 2) Newly diagnosed and histologically confirmed glioblastoma (WHO grade IV) in supratentrial brain without dissemination. 3) Maximum surgical resection was performed. 4) Enough mass of tumor reserved as fixed specimen. 5) Karnofsky performance scale is equal to or more than 60 %, and life expectancy expected at least 3months. 6) Standard radiotherapy in 60 Gy will be performed. 7) Patient informed his/her diagnosis, and has enough ability to comprehend and consent to the study. 8) Vaccination and follow‐up will perform under the institutions.
Epistemonikos ID: bf95a34f44988f9f50831a77dc95caae7ce247de
First added on: Aug 22, 2024