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RECRUITING
NCT03213002
PHASE1/PHASE2

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

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.

Official title: Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2017-06-13

Completion Date

2027-06

Last Updated

2025-04-09

Healthy Volunteers

No

Interventions

DRUG

Capecitabine

Capecitabine at 1500 mg/m2

DRUG

Temozolomide

Temozolomide at 150 mg/m2 - 200 mg/m2

Locations (1)

Lenox Hill Brain Tumor Center

New York, New York, United States