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6 Months Adjuvant Temozolomide (TMZ) vs No Adjuvant TMZ in Newly Diagnosed MGMT Methylated Glioblastoma (GBM)

NCT04926168 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-08-10

No results posted yet for this study

Summary

The primary objective of this trial is to evaluate overall survival of patients with O\[6\]-methylguanine-DNA methyltransferase (MGMT) methylated glioblastoma treated with or without six months of adjuvant TMZ after standard radiation (6000 centigray (cGy)) plus concurrent Temozolomide (TMZ).

Secondary Objectives include to prospectively assess the overall adverse event profile in the two treatment arms. To compare lymphocyte counts overtime between the two treatment arms and to prospectively compare quality of life in the two treatment arms as assessed by MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) and Neurological quality of Life/minimal infecting dose (NeuroQoL) (MID). The study will also compare progression-free survival between the two treatment arms.

Conditions

  • MGMT-Methylated Glioblastoma

Interventions

OTHER

Delay of TMZ

Delay of TMZ to analyze the current standard of care practice of prescribing TMZ post combination (RT and TMZ).

OTHER

Standard of Care (SOC) Adjuvant TMZ (no intervention

SOC in Adjuvant Setting no intervention

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Stuart Grossman, MD · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04926168 on ClinicalTrials.gov