EVALUATION OF COGNITIVE FUNCTION IN ELDERLY PATIENTS WITH GLIOBLASTOMA IN RADIO OR CHEMOTHERAPY

DIFFERENCE BETWEEN NEUROCOGNITIVE IMPACT WITH CHEMOTHERAPY AND RADIATION THERAPY HYPOFRACTIONATED TEMOZOLOMIDE AS SINGLE AGENT IN ELDERLY PATIENTS (= 70 YEARS) WITH NEWLY DIAGNOSED GLIOBLASTOMA: A MULTICENTER STUDY - COGNITIVE FUNCTION IN ELDERLY GLIOBLASTOMA

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002751-10-IT

Enrollment

138

Registered

2021-09-30

Start date

2015-10-05

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NEWLY DIANGOSED GLIOBLASTOMA ELDERLY PATIENTS MedDRA version: 20.0 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: TEMOZOLOMIDE TEVA - 100 MG - CAPSULE RIGIDE - USO ORALE - FLACONE (VETRO)" 5 CAPSULE Product Name: temozolomide Pharmaceutical Form: Capsule, hard INN or Proposed INN: TEMOZOLOMIDE CAS Num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. = 70 years 2. Karnofsky Performance Score (KPS) = 60 3. Newly diagnosed GBM intracranial histologically confirmed after biopsy or resection no more than 4-6 weeks prior to treatment; 4. Adequate bone marrow function (WBC = 3000 / ul, absolute neutrophil count = 1500 / ul, platelet count = 100,000 / mm3, and hemoglobin = 9 g / dL), hepatic (AST and ALT 50 / mL / min) before starting therapy 5. Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 138

Exclusion criteria

Exclusion criteria: Presence of psychiatric disorders that may interfere with the feedback or neuro cognitive understanding of informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of neurocognitive function in elderly patients (= 70 years) with GBM treated with RT or hypofractionated TMZ as single agent;Secondary Objective: 1. Overall survival 2. Evaluation of quality of life 3. Evaluation of tolerance to treatment ;Primary end point(s): Hopkins Verbal Learning Test-Revised (HVLT-R), item "Total Recall", after 6 months of treatment ;Timepoint(s) of evaluation of this end point: 6 MONTHS	—

Measure

Time frame

Main Objective: Assessment of neurocognitive function in elderly patients (= 70 years) with GBM treated with RT or hypofractionated TMZ as single agent;Secondary Objective: 1. Overall survival 2. Evaluation of quality of life 3. Evaluation of tolerance to treatment ;Primary end point(s): Hopkins Verbal Learning Test-Revised (HVLT-R), item "Total Recall", after 6 months of treatment ;Timepoint(s) of evaluation of this end point: 6 MONTHS

—

Secondary

Measure	Time frame
Secondary end point(s): OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; TOXICITY (CTC);Timepoint(s) of evaluation of this end point: DEATH OR TWO YEARS FOLLOW-UP; DEATH OR PROGRESSION; MONTHLY	—

Countries

Italy

Contacts

Public ContactVERONICA VILLANI

IFO

villani@ifo.it065291103

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026