Phase 2
Completed N=30
Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform
Source: ClinicalTrials.gov NCT01120639 ↗Enrolled (actual)
30
Serious AEs
70.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Dose-limiting Toxicities (DLTs) — 0; 0; 0; 1 Number of DLT observed
Summary
The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Dose-limiting Toxicities (DLTs) |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Acute Toxicity Within 30 Days |
5; 2; 2; 4; 0; 0 | — |
| SECONDARY Long-term Toxicity After More Than 30 Days |
0; 0; 1; 1; 0; 1 | — |
| SECONDARY Percent of Participants With Radiographic Response |
100; 100; 100; 33.3; 66.7; 66.7 | — |
| SECONDARY Progression-free Survival |
13.4; 10.5; 33.5; 3.9; 7.2; 6.5 | — |
| SECONDARY Overall Survival (OS) |
17.6; 19.9; 48.3; 10.2; 10.1; 11.3 | — |
| SECONDARY Quality of Life by European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30) Survey |
41.6; 58.3; 80.5; 53.3; 41.6; 52.7 | — |
| SECONDARY Quality of Life by Brain-20 Survey |
66.6; 40.7; 18.5; 44.4; 40.7; 55.5 | — |
| SECONDARY Quality of Life by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Survey |
5.2; 2.0; 2.8; 3.2; 3.7; 3.2 | — |
| SECONDARY Treatment Failure Analysis |
2; 5; 2; 8; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
- The tumor must be supratentorial in location
- The planning target volume (tumor plus margin) must measure ≤ 150 cm^3 in volume
- Age ≥ 18 years
- Life expectancy of at least 12 weeks
- Patient must have adequate organ function to tolerate temozolomide (details in the protocol)
Exclusion Criteria
- Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
- Tumor foci detected below the tentorium
- Multifocal disease or leptomeningeal spread
- Prior allergic reaction to the study drugs involved in this protocol
- Patients with pacemaker will be allowed to undergo CT instead of MRI
- Pediatric patients (age < 18), pregnant women, and nursing patients will be excluded
Data sourced from ClinicalTrials.gov (NCT01120639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.