Phase 12 Study of Oral Capecitabine and Temozolomide Combination for Newly Diagnosed Glioblastoma Multiforme GBM

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining the oral chemotherapy drugs capecitabine and temozolomide to treat adults newly diagnosed with glioblastoma multiforme GBM, a serious brain cancer. The study aims to see if adding capecitabine to the standard treatment with temozolomide after radiation can help patients respond longer and better to therapy. This trial is conducted in phases 1 and 2 to explore dosing and effects in this patient group. Participants will take capecitabine at a dose of 1500 mgm2 divided into two daily doses for the first 14 days of each 28-day cycle. Temozolomide will be given at 150 mgm2 to 200 mgm2 divided into two doses from days 10 to 14, followed by 14 days off. This dosing schedule is designed to follow the initial six weeks of radiation and concurrent temozolomide treatment known as the Stupp protocol. The study focuses on the maintenance phase of treatment after radiation. Participants will be closely monitored through medical exams, lab tests, and imaging scans to measure progression-free survival at six months and overall survival up to four years. Side effects will be recorded and graded. Researchers will also assess overall response rates using standard criteria. The study duration may last several years, with ongoing safety checks and quality-of-life assessments to understand how well the treatment works and its impact on patients.

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM