Clinical trial · Interventional
Temozolomide in Elderly Patients With KPS < 70
Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).
NCT01242566CI-TRIAL-00004117TAGcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The management of glioblastoma in elderly patients with poor performance status (KPS\<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population
Conditions
Conditions (2)
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 | Glioblastoma | CURATED_BROADER | 0.80 |
| Primary Brain Tumor | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- temozolomide
- description
- Administration of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity
- interventionNames
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 12 months
Secondary outcomes (5)
- measure
- Progression-free survival
- timeFrame
- 12 months
- measure
- adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed supratentorial glioblastoma * Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy * Patients aged 70 years or older * KPS above 30 and below 70 * Life expectancy higher than 4 weeks * Clinical examination at baseline * Affiliation to Social Security or mandatory beneficiary * Patient being informed and obtention of written informed consent Exclusion Criteria: * Prior surgical resection dated more than 1 month before inclusion * Prior brain radiotherapy or chemotherapy * Severe underlying disease which could interfere with survival * History of hypersensibility reaction on temozolomide components * Severe bone marrow hypoplasia * Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal * Absolute neutrophil count \< 1.5x109 cells per liter * Platelet count \< 100x109 cells per liter * Hemoglobin \< 9 g/dl * Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy
References
Publications (0)
Data not yet available
No reference posted for this study.