Spots Global Cancer Trial Database for Bevacizumab Alone Versus Dose-dense Temozolomide Followed by Bevacizumab for Recurrent Glioblastoma, Phase III
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Trial Identification
Brief Title: Bevacizumab Alone Versus Dose-dense Temozolomide Followed by Bevacizumab for Recurrent Glioblastoma, Phase III
Official Title: A Multicenter Randomized Phase III Study for Recurrent Glioblastoma Comparing Bevacizumab Alone With Dose-dense Temozolomide Followed by Bevacizumab (JCOG1308C, RE-GEND-pIII)
Study ID: NCT02761070
Study Description
Brief Summary: The aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or progression, comparing to bevacizumab alone.
Detailed Description: Glioblastoma (GBM), the most frequent malignant primary brain tumor, has yet been incurable despite recent progress on its standard of care using TMZ as the main trunk of initial therapy in the newly diagnosed setting. One of the main reasons accounting for the dismal prognosis would attribute to lack of active therapeutic regimens at recurrence. Bevacizumab, a humanized monoclonal antibody against cardinal angiogenic factor vascular endothelial growth factor (VEGF), has recently shown efficacy for recurrent GBM, and has been approved in Japan, thereby being a standard care for recurrent GBM. Since there is no effective drugs or regimens developed at bevacizumab failure, insertion of another active drug prior to bevacizumab induction would enhance survival time for patients with recurrent GBM. In Japan, there are currently only few chemotherapeutic agents approved and available for GBM. Among them rechallenge with alternating dosing of TMZ have shown certain efficacy with acceptable toxicities for patients with TMZ-pretreated recurrent GBM, thus being a good candidate for the regimen used prior to bevacizumab at recurrence. The present proposal of sequential administration of dose dense TMZ (7/14d) followed by bevacizumab wishes to define a new standard of care for recurrent disease and hopes to identify the subgroups of patients with progressive or recurrent glioblastoma that respond particularly well to dose-dense temozolomide regimens. This study is carried out as a JCOG Brain Tumor Study Group multicenter randomized phase III trial under approval by Advanced Medical Care B system, Ministry of Health, Labour and Welfare, Japan.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Nagoya University Hospital, Nagoya, Aichi, Japan
Fujita Health University Hospital, Toyoake, Aichi, Japan
Hirosaki University School of Medicine, Hirosaki, Aomori, Japan
Ehime University Graduate School of Medicine, Shizukawa, Ehime, Japan
Kurume University Hospital, Kurume-shi, Fukuoka, Japan
Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan
Kobe University Hospital, Kobe, Hyougo, Japan
University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan
Iwate Medical University, Morioka, Iwate, Japan
Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
Nagasaki University Hospital, Nagasaki-shi, Nagasaki, Japan
Kansai Medical University, Hirakata, Osaka, Japan
Osaka University Graduate School of Medicine, Suita, Osaka, Japan
Saga University Hospital, Saga-shi, Saga, Japan
Saitama Medical University International Medical Center, Hidaka, Saitama, Japan
Dokkyo Medical University, Shimotsuge, Tochigi, Japan
Tokyo Medical And Dental University, Medical Hospital, Bunkyō-Ku, Tokyo, Japan
University of Yamanashi, Chuo-shi, Yamanashi, Japan
Chiba University Hospital, Chiba, , Japan
Kusyu University Graduate School of Medical Sciences, Fukuoka, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, , Japan
Kitasato University School of Medicine, Kanagawa, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Kyoto University Graduate School of Medicine, Kyoto, , Japan
Niigata University Medical & Dental Hospital, Niigata, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Nakamura Memorial Hospital, Sapporo, , Japan
Hokkaido University Graduate School of Medicine, Sapporo, , Japan
Shizuoka Canser Center Hospital, Shizuoka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
The University of Tokyo Hospital, Tokyo, , Japan
Keio University Hospital, Tokyo, , Japan
Nihon University School of Medicine Itabashi Hospital, Tokyo, , Japan
Kyorin University Faculty of Medicine, Department of Neurosurgery, Tokyo, , Japan
Yamagata University Hospital, Yamagata, , Japan
Contact Details
Name: Motoo Nagane, M.D., Ph.D.
Affiliation: Kyorin University Faculty of Medicine, Department of Neurosurgery
Role: STUDY_CHAIR
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