Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02780024 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Metformin, Neo-adjuvant Temozolomide and Hypo- Accelerated Radiotherapy Followed by Adjuvant TMZ in Patients With GBM

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Study completion date: Feb 28, 2026 to Feb 28, 2027v13
  2. Minor Re-verified, no change to tracked fieldsv12
  3. Notable Primary completion date: Apr 21, 2021 to Oct 20, 2021
    • Study completion date: Feb 28, 2022 to Feb 28, 2026
    v11
  4. Minor Primary completion date changed from estimate of Dec 2021 to Apr 21, 2021
    • Study completion date: Dec 2023 to Feb 28, 2022
    v10
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Primary completion date: Dec 2020 to Dec 2021
    • Study completion date: Dec 2022 to Dec 2023
    v8
  2. Minor 2 versions Re-verified since Oct 27, 2020, no change to tracked fieldsv6-v7
  3. Notable Primary completion date: Dec 2019 to Dec 2020
    • Study completion date: Dec 2021 to Dec 2022
    • Site contact updated
    v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Notable Primary completion date: Dec 2018 to Dec 2019
    • Study completion date: Dec 2020 to Dec 2021
    • Study site revised
    v3
  6. Notable Primary endpoint revisedv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Glioblastoma Multiforme is one of the most common, and unfortunately one of the most aggressive brain tumors in adults with most of the patients recurring and dying of the disease with a median survival of 16 months from diagnosis. Current treatment for patients with newly diagnosed Glioblastoma Multiforme (GBM) is safe maximal surgical resection followed by concomitant conventional Radiotherapy (RT) delivered in 6 weeks + Temozolomide (TMZ) followed by TMZ for 6 to 12 cycles. Recent scientific research has shown that Metformin, a common drug used to treat diabetes mellitus, may improve the results of the treatment in patients with a variety of cancers, such as breast, colon, and prostate cancer. Metformin is an attractive and safe medication to be used in this group of patients because of its very low toxicity. In our center the investigators have been using TMZ for 2 weeks prior to a short course (4 weeks) of RT which equivalent to the standard RT of 6 weeks. Temozolomide is used 2 weeks before RT + TMZ, and this is followed by the 6 to 12 cycles of TMZ. Our results are quiet encouraging with a median survival of 20 months, and acceptable toxicity.
Trial Details
NCT Number NCT02780024
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)
Glioblastoma Multiforme
Related terms Glioblastoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov