Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.
- Conditions
- anaplastic glioma without 1p/19q deletiongrade III non-1p/19q deleted glioma10029211
- Registration Number
- NL-OMON41635
- Lead Sponsor
- European Organisation for Research in Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>overall survival as measured from the day of randomization (section 8.2.1.1,<br /><br>page 38)</p><br>
- Secondary Outcome Measures
Name Time Method <p>progression free survival, neurological progression free survival as determined<br /><br>with the WHO Performance status, cognition as assessed with the Mini Mental<br /><br>Status Examination (MMSE) and with the use of a short neuropsychological<br /><br>testbattery, toxicity of temozolomide treatment (chapter 7) and quality of life<br /><br>assessed with the EORTC QOL C30 questionnaire and the Brain Cancer Module<br /><br>(chapter 10, chapter 8).</p><br>