Clinical trial · Interventional
Phase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with GBM, who were deemed ineligible for any active protocols at our centre, received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated with a median KPS of 90 (range 50-100). Four patients had multicentric disease at presentation. Eight patients had biopsy only while the rest had a near total resection (n=14) and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was 14.4 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Mutliforme | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT and accelerated hypofractionation technique | Radiation | — | UNRESOLVED |
| IMRT Technique | Radiation | — | UNRESOLVED |
| neo-adjuvant TMZ followed by accelerated hypofractionated EBRT | Radiation | — | UNRESOLVED |
| Temozolomide and Accelerated Hypofractionation RT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide, Accelerated Hypofractionated RT
- description
- Patient will receive two weeks of neo-adjuvant Temozolomide followed by Accelerated Hypofractionated RT for a total of 20 fractions for a total of 60Gy followed by Temozolomide for 12 cycles.
- interventionNames
- Radiation: IMRT Technique
- Radiation: IMRT and accelerated hypofractionation technique
- Radiation: neo-adjuvant TMZ followed by accelerated hypofractionated EBRT
- Drug: Temozolomide and Accelerated Hypofractionation RT
Primary outcomes (2)
- measure
- Percent of patients completing the study treatment
- timeFrame
- At one year
- description
- To determine overall survival.
- measure
- To assess toxicity of the regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 years or older * Histological confirmation of supratentorial GBM * KPS \> 60 * Neurological function 0 or 1 * Adequate bone marrow as defined below: * absolute neutrophil count (ANC) \> 1500 cells/mm3 * platelets \> 100,000 cells/mm3 * hemoglobin \> 10g/dl * Adequate renal function as defined below: * BUN \< 25mg/dl within 14 days prior to study registration * creatinine of 63 to 103 umol/L within 14 days prior to study registration * Adequate hepatic function as defined below: * Bilirubin of 3 to 21 umol/L within 14 days prior to study registration * ALT \& AST \< 3xnormal range within 14 days prior to study registration * Neoadjuvant TMZ to start within 3 weeks of surgery/biopsy if no resection was deemed feasible * A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively. * History, physical and neurological examination within 14 days prior to study registration. * For females of child-bearing potential, negative pregnancy test within 72 hours prior to starting TMZ. * Able to sign an informed study-specific consent Exclusion Criteria: * Margin of contrast-enhanced residual mass closer than 15mm from the optic chiasm or optic nerves. * Prior invasive malignancy, unless disease-free for \>3years * Recurrent or multifocal GBM * Severe co-morbidities such as * unstable angina * transmural myocardial infarction within 6 months * COPD at the time of registration * Hepatic insufficiency * Bacterial or fungal infection requiring IV antibiotics at the time of registration * Acquired Immune Deficiency Syndrome (AIDS) * Major medical illnesses or psychiatric impairments * Pregnant women or lactating women
References
Publications (1)
- DERIVEDShenouda G, Souhami L, Petrecca K, Owen S, Panet-Raymond V, Guiot MC, Corredor AG, Abdulkarim B. A Phase 2 Trial of Neoadjuvant Temozolomide Followed by Hypofractionated Accelerated Radiation Therapy With Concurrent and Adjuvant Temozolomide for Patients With Glioblastoma. Int J Radiat Oncol Biol Phys. 2017 Mar 1;97(3):487-494. doi: 10.1016/j.ijrobp.2016.11.006. Epub 2016 Nov 15. PMID 28011051