anaplastic glioma 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)
Conditions
Sponsors
EORTC European Organisation for research and treatment of cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: AT REGISTRATION: - Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis - Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review. - WHO performance status 0-2 - Age = 18 years - All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding - Absence of known HIV infection, chronic hepatitis B or hepatitis C infection - Absence of any other serious medical condition that can interfere with follow-up - Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction) -Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial RANDOMIZATION: The combination of Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis AND Absence of combined 1p/19q loss both of which must have been determined by either local testing or central review - Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review - WHO performance status 0-2 - Age = 18 years - Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression - Start of radiotherapy within 8 days from randomization - Start of radiotherapy within 7 weeks (49 days) from surgery (extra 2 days could be allowed) - Patients must be on a stable or decreasing dose of steroids for at least two weeks - Adequate hematological, renal and hepatic function - All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding - Absence of known HIV infection, chronic hepatitis B or hepatitis C infection - Absence of any other serious medical condition that could interfere with follow-up Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 748 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: REGISTRATION: - Previous other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to registration, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix. - Prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel®) - Prior radiotherapy to the brain RANDOMIZATION: - Prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel®) - Prior radiotherapy to the brain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma. - To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in patients with non-1p/19q deleted anaplastic glioma;Secondary Objective: - To assess whether concurrent and adjuvant temozolomide treatment prolongs progression free survival and neurological deterioration free survival in patients with non-1p/19q deleted anaplastic glioma. - To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition. - To assess the impact of concurrent and adjuvant emozolomide treatment on the quality of life in patients with non-1p/19q deleted anaplastic glioma.;Primary end point(s): The primary endpoint of the study is overall survival, as measured from the day of randomization.;Timepoint(s) of evaluation of this end point: Median 3, 4 and 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints of the study are progression free survival, neurological deterioration free survival, quality of life, toxicity, and development of cognitive deterioration.;Timepoint(s) of evaluation of this end point: Progression free survival: Median 3, 4 and 5 years Neurological deterioration free survival: Median 3, 4 and 5 years Quality of Life (QOL): - Overall comparison of QOL scores up to Progression Disease. - Comparison at 4 weeks of Radiotherapy (RT) and every 3 monthly visit up to progression disease Toxicity: worst grade: -during RT or concomitant Temozolomide (TMZ)/RT - during adjuvant TMZ - Follow-up period Mini mental status examination: median time till cognitive deterioration | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs Department
European Organisation for Research and Treatment of Cancer (EORTC)
Outcome results
None listed