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Prospective randomized Study with Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme

Prospective randomized Study with Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme

Temodal Trial

General Information
Research Type
Interventional
Description
This is a single center, open label, parallel group randomized trial designed to evaluate the efficacy and safety of Temozolomide and radiotherapy compared to radiotherapy alone for a treatment period of up to 34 weeks.
60 patients with glioblastoma multiforme from one participating sites who meet inclusion/exclusion criteria will be enrolled into the trial.

After initial screening, patients will attend clinic for baseline examination. Subjects will then be randomly allocated to Temozolomide and radiotherapy or radiotherapy alone in a ratio of 1:1.
Subjects who are randomized to Temozolomide will undergo 6 weeks of therapy together with radiotherapy, followed by 4 weeks of rest. Thereafter, up to 6 cycles of Temozolomide treatment, each cycle lasting 28 days (4 weeks). Total potential duration of treatment is therefore 34 weeks
Study Information
RMK Priority Area
Research Level
Research Keyword
Temodal, Temozolomide, chemotherapy, Glioblastoma Multiforme
Inclusion & Exclusion Criteria
Inclusion Criteria
The study population consists of newly diagnosed male or female patients with glioblastoma multiforme at a participating site

Inclusion criteria
1. Written informed consent obtained from patient or parents/guardian.
2. Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade IV). The histological diagnosis is made locally after biopsy or neurosurgical tumor resection.
3. Age: ≥18 and ≤ 70 years.
4. WHO performance status ≤ 2.
5. Stable, non-increasing dose of corticosteroids.
6. Adequate hematological, renal and hepatic function according to all of the following laboratory values to be performed within 14 days, inclusive, prior to randomization:
-Absolute neutrophil count ≥1.5 x 109/l;
-Platelets ≥ 100 x 109/l;
-Serum creatinine ≤ 1.5 times upper limit of laboratory normal;
-Total serum bilirubin ≤ 1.5 times upper limit of laboratory normal;
-ASAT and ALAT < 3 times upper limit of laboratory normal;
-Alkaline phosphatase of < 3 times upper limit of laboratory normal.
7.Initial surgery/biopsy performed ≤ 6 weeks (42 days) prior to randomization
8.Presence of medically approved contraception in any fertile (M/F) patient.
-It is strongly recommended that women with childbearing potential have a negative urine or serum pregnancy test (urinary excretion or serum level of bHCG) within 72 hours of randomization.

Exclusion criteria
1. Prior chemotherapy.
2. Presence of known HIV infection, chronic hepatitis B or hepatitis C infection;
3. Presence of any other serious medical condition according to the medical judgment of the physician prior to randomization.
4. Presence of any medical condition, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
5. Presence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non-melanoma skin cancer.
6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before randomization.
7. Presence of known or suspected hypersensitivity to temozolomide or other imidazotetrazinones.
Exclusion Criteria
The study population consists of newly diagnosed male or female patients with glioblastoma multiforme at a participating site

Inclusion criteria
1. Written informed consent obtained from patient or parents/guardian.
2. Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade IV). The histological diagnosis is made locally after biopsy or neurosurgical tumor resection.
3. Age: ≥18 and ≤ 70 years.
4. WHO performance status ≤ 2.
5. Stable, non-increasing dose of corticosteroids.
6. Adequate hematological, renal and hepatic function according to all of the following laboratory values to be performed within 14 days, inclusive, prior to randomization:
-Absolute neutrophil count ≥1.5 x 109/l;
-Platelets ≥ 100 x 109/l;
-Serum creatinine ≤ 1.5 times upper limit of laboratory normal;
-Total serum bilirubin ≤ 1.5 times upper limit of laboratory normal;
-ASAT and ALAT < 3 times upper limit of laboratory normal;
-Alkaline phosphatase of < 3 times upper limit of laboratory normal.
7.Initial surgery/biopsy performed ≤ 6 weeks (42 days) prior to randomization
8.Presence of medically approved contraception in any fertile (M/F) patient.
-It is strongly recommended that women with childbearing potential have a negative urine or serum pregnancy test (urinary excretion or serum level of bHCG) within 72 hours of randomization.

Exclusion criteria
1. Prior chemotherapy.
2. Presence of known HIV infection, chronic hepatitis B or hepatitis C infection;
3. Presence of any other serious medical condition according to the medical judgment of the physician prior to randomization.
4. Presence of any medical condition, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
5. Presence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non-melanoma skin cancer.
6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before randomization.
7. Presence of known or suspected hypersensitivity to temozolomide or other imidazotetrazinones.
Study Timeline
Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data
Dec, 31 2002
Expected / Actual Date Study Completed
Expected / Actual Duration of Study Enrollment / Data Collection