OncoMatch/Clinical Trials/NCT03213002
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
Is NCT03213002 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Capecitabine and Temozolomide for glioblastoma multiforme (gbm).
Treatment: Capecitabine · Temozolomide — The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Disease stage
Required: Stage IV
Prior therapy
Must have received: chemoradiation (temozolomide) — Stupp protocol, during radiation
Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide
Cannot have received: capecitabine (capecitabine)
Prior chemotherapy with capecitabine
Cannot have received: temozolomide (temozolomide)
Exception: except during radiation for newly diagnosed GBM or AA
Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation
Cannot have received: fluoropyrimidine (continuous infusion 5-FU)
Patients previously treated with continuous infusion 5-FU
Cannot have received: alkylating agent (DTIC)
any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded
Lab requirements
Blood counts
adequate bone marrow function before commencing therapy
Kidney function
adequate renal function before commencing therapy
Liver function
adequate liver function before commencing therapy
adequate bone marrow function, liver function and renal function before commencing therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lenox Hill Brain Tumor Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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