Surgery Clinical Trial
Official title:
Phase II Study of Neoadjuvant Chemoradiation for Resectable Glioblastoma (NeoGlio)
Preoperative therapy has not been well studied in resectable glioblastoma. This study attempts to prospectively assess the feasibility and efficacy of preoperative chemo radiation in improving local control, as this is the predominant mode of failure in these patients leading to poor outcomes. This Phase II study design would be used to proceed with the study treatment after meeting pre-specified events in the initial phase, with goal being to determine whether the new treatment paradigm is sufficiently promising to warrant a major controlled clinical evaluation against the standard therapy.
Neo adjuvant, preoperative chemo radiation has consistently shown improvements in local disease control or organ preservation in many cancers including head and neck, esophageal, rectal, bladder cancers and sarcomas, leading to improvements in overall survival and limb or organ preservation. This interventional study will be done in two phases using the Simon two-stage Phase II study design. The median progression-free survival of these patients with current standard of care therapy is in the range of 6-8 months (6.9 months in the standard of care). With the proposed trial of surgical resection of the tumor after chemotherapy and radiation the median progression free survival is anticipated to be approximately 11-12 months from subset analysis of available literature and based on prior data on other disease sites. In other words, the 7-month local progression rates is anticipated to decrease from 50% to 25%, or progression free survival improve from 50-75% ;
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