A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATIONVERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS

Phase 1

• Conditions: Elderly (>65 years of age) patients with newly diagnosed, and histopathologically confirmed, glioblastoma multiforme (GBM, WHO grade IV) , who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60 Gy / 30 fractions over 6 weeks) in combination with temozolomide.; MedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiforme

• Registration Number: EUCTR2008-001949-26-FR
• Lead Sponsor: EORTC European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-25
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

Patients must fulfill all of the following criteria to be eligible for admission to the study:

1. Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade IV). The histological diagnosis must have been made after biopsy or neurosurgical tumour resection.

2. Initial surgery/biopsy at diagnosis performed < 4 weeks (28 days) prior to randomization.

3. Patient’s age is > 65 years.

4. Patient is not deemed suitable by the treating physician to receive the standard radiotherapy regimen (60 Gy / 30 fractions over 6 weeks) in combination with temozolomide.

5. ECOG performance status of 0, 1 or 2.

6. Patient may have received and continue to receive corticosteroids, but s/he have to be on a stable or decreasing dose for at least 14 days prior to randomisation.

7. Patient has not received prior chemotherapy or radiotherapy.

8. Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to randomisation:
- Absolute granulocyte count (AGC) = 1.5 x 109/L (1,500 cells/mm3)
- Platelet count = 100 x 109/L (100,000 cells/mm3)
- Serum creatinine = 1.5 times the upper limit of normal
- Total serum bilirubin = 1.5 times the upper limit of normal
- ALT (SGPT) < 2.5 times the upper limit of normal
- and/or AST (SGOT) < 2.5 times the upper limit of normal

9. Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French or any other official language into which the questionnaire is required to be translated. The baseline assessment must have already been completed. Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the
patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.

10. Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. A copy of the initial full board REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomisation.

11. Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomised on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

12. All other investigations (physical examination, biochemistry and hematology tests etc.) as listed in section 6.0 of the protocol have been performed prior to randomisation (with the exception of requests for diagnostic tissue blocks / slides to be used for central pathology review and correlative studies which will be done after
randomisation).

13. Protocol treatment is to begin within 2 weeks of patient randomisation.
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

Exclusion Criteria

Patients who fulfill any of the following criteria are not eligible for admission to the study:

1. Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for = 5 years.

2. Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) at the time of randomisation or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment.

3. Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.

4. Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide.

5. Patients who have had treatment with any investigational cancer drug prior to randomisation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified