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Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Study acronym: CAPTEM
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jun 2026 to Jun 2028 Completion date: Jun 2027 to Jun 2029v9 Show 1 more changeShow less
    • Completion date: Jun 2027 to Jun 2029
  2. Completion date: Jun 2026 to Jun 2027v8
  3. Primary and study completion dates: Jun 2024 to Jun 2026v7
  4. Re-verified, no change to tracked fieldsv6
  5. Primary and study completion dates: Jun 2021 to Jun 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. 2 versions Re-verified since Nov 18, 2019, no change to tracked fieldsv3-v4
  2. Study title shortened, about 4 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Northwell Health
133 trials monitored
See 10 trials at risk
Glioblastoma
670 trials monitored
See 44 trials at risk
Glioma
668 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT03213002
Lead Sponsor Northwell Health
Conditions Glioblastoma Multiforme (GBM), Glioblastoma, Glioma of Brain, Glioblastoma, Adult, Brain Tumor, Brain Tumor, Primary, Brain Tumor Adult, Cancer +1 more
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov