Phase III intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with concomitant and adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma.
- Conditions
- anaplastic oligodendroglial tumors10029211
- Registration Number
- NL-OMON44004
- Lead Sponsor
- European Organisation for Research in Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
* Provide informed written consent.
* Patient willing to provide tissue samples for deletion status
* *18 years of age.
* Newly diagnosed and <3 months from surgical diagnosis.
* Histological confirmation of anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma (grade 3-4)
* Loss of heterozygosity for both 1p and 19q (*co-deletion*).
* *2 weeks from the date of surgery and must have recovered from the effects of surgery
* Adequate hematological, renal and liver function
* Negative pregnancy test (B-HCG) done *7 days prior to registration, for women of childbearing potential only.
* Willing and able to complete neurocognitive/QOL questionnaire(s) by themselves or with assistance
* ECOG performance status (PS) of 0 1 or 2
* For women: not pregnant or nursing, for all patients of childbearing potential: willing to employ adequate contraception
* No prior surgery, radiotherapy or chemotherapy for any CNS neoplasm
* No co-morbid systemic illnesses or other severe concurrent disease which, would interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
* No concomitant serious immuno-compromised status (other than that related to concomitant steroids).
* No active uncontrolled systemic infection or HIV.
* Not receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
* No active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix. If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer.
* No history of myocardial infarction *6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overall survival, primary question: does the addition of temozolomide<br /><br>chemotherapy to radiotherapy increase overall survival?</p><br>
- Secondary Outcome Measures
Name Time Method <p>Time to event which is defined as the time from study registration to the<br /><br>earliest evidence of 1) clinical progression, 2) radiographic progression, or<br /><br>3) neurocognitive progression, whichever comes first</p><br>