Phase III intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with concomitant and adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 488

Inclusion Criteria

1- >18 years of age.
2-Newly diagnosed and =3 months from surgical diagnosis.
3- Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [grade 3]), as determined by pre-registration central pathology review, and tumor is also co-deleted for 1p and 19q
4- Surgery =2 weeks prior to registration must have recovered from the effects of
surgery.
5-Negative pregnancy test done =7 days prior to registration, for women of
childbearing potential only.
6- Willing and able to complete neurocognitive examination without assistance and the QOL by themselves or with assistance (see Section 4.4).
7- ECOG performance status (PS) of 0, 1 or 2
8- Provide informed written consent.
9- Patient willing to provide tissue samples for research purposes

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1-Any of the following because this study involves an agent that has known
genotoxic, mutagenic and teratogenic effects:
•Pregnant women
•Nursing women
•Men or women of childbearing potential who are unwilling to employ adequate contraception
2-Received any prior surgery, radiotherapy or chemotherapy for any CNS neoplasm (hormones, vitamins and growth factors are not considered chemotherapy for the purposes of this study).
3- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
4- Concomitant serious immuno-compromised status (other than that related to
concomitant steroids).
5- Active uncontrolled systemic infection or HIV.
6- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
7- Active other malignancy, excepting non-melanotic skin cancer or carcinoma-insitu of the cervix.
8- History of myocardial infarction =6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
9- Recent history of hepatitis infection or treating physician determined that the patient would be at significant risk of reactivation of hepatitis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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