| Literature DB >> 18845525 |
Toshihiko Wakabayashi1, Takamasa Kayama, Ryo Nishikawa, Hiroshi Takahashi, Toshiki Yoshimine, Nobuo Hashimoto, Tomokazu Aoki, Kaoru Kurisu, Atsushi Natsume, Masatoshi Ogura, Jun Yoshida.
Abstract
A multicenter phase I clinical trial, namely, Integrated Japanese Multicenter Clinical Trial: A Phase I Study of Interferon-beta and Temozolomide for Glioma in Combination with Radiotherapy (INTEGRA Study), is being conducted for patients with high-grade glioma in order to evaluate the safety, feasibility and preliminary clinical effectiveness of the combination of interferon-beta and temozolomide. The primary endpoint is incidence of adverse events. The secondary endpoints are progression-free survival time and overall survival time. In addition, objective tumor response will be evaluated in a subpopulation of patients with the measurable disease. The reduction rate of tumor will be calculated according to Response Evaluation Criteria In Solid Tumors for measurable tumors as determined by magnetic resonance imaging. Subsequently, the overall response will be evaluated based on the results of measurable and non-measurable tumors. Ten newly diagnosed and 10 recurrent patients will be enrolled in this study.Entities:
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Year: 2008 PMID： 18845525 DOI： 10.1093/jjco/hyn095
Source DB: PubMed Journal: Jpn J Clin Oncol ISSN： 0368-2811 Impact factor: 3.019