Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

There were an estimated 22,000 new cases of brain cancers in 2015 in the United States, and 15,000 deaths (Howlader et al., 2014). Glioblastoma (WHO IV), and Anaplastic Astrocytoma (WHO III), are the most common brain cancers, respectively, representing over 70% of all malignant gliomas (ABTA, 2015). Though rare, there is no cure, and the prognosis for these tumors is poor. Survival at 5 years for all CNS cancers is approximately 33.3 % (Howlader et al., 2014). For GBM, the most lethal of the tumors, with the current standard of care median survival is 14.6 months (Walid, 2008). Relative survival with GBM at five years is approximately only 5% (Ostrom et al. CBTRUS 2014). For newly diagnosed tumors, the current standard of care recommends a multi-modal approach with surgery to remove the tumor, when possible, followed by 6 weeks of radiation and a concurrent daily dose of temozolomide (Stupp et al. 2005). This is known as the Stupp protocol (Stupp et al. 2005). Patients then have a one-month rest period with no treatment, followed by "maintenance" temozolomide, given five days out of every 28 days, for a minimum of six months. Some providers keep patients on temozolomide beyond 6 months, or until disease progression. Therefore, more therapies are needed to help improve survival, reduce time to recurrence and improve quality of life for these patients. This trial proposes to improve the current standard of care by enhancing the efficacy of an active drug temozolomide, currently used for treatment of GBM.