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Study Summary
No. RTOG98-13:.......CNS; Neural; CTRC(Translational Research)......W K Alfred Yung......Neuro Oncology
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Study Summary Title
Study Summary
Number:		RTOG98-13
Study Title:A PHASE III (Phase I Closed) RAND. STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VS.RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA (IND #60,265) Versus RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA AND MIXED ANAPLASTIC OLIGOASTROCYTOMA
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Physician New Patient Referral
Name:W K Alfred YungPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Neuro OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-1285
Contact us about clinical trials
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General Information
Disease Group:CNS
Neural
CTRC(Translational Research)		Supported By:RTOG
Phase of Study:Phase IReturn
Visit:		Daily 5 days per week for 6 weeks, then once every 6-8 wks for 1 year.
Treatment
Agents:		Temozolomide
BCNU		Home Care:Temozolomide administration
Treatment Loc:outpatient
Estimated
Length of Stay
in Houston:		None
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:03/24/2003
IRB Review and Approval Date:08/02/2000
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:195
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:Karnofsky performance status >/=60.

Pre & post-op contrast-enhanced MRI.

If pt had only a stereotactic biopsy, then a post biopsy scan is not necessary.

Signed informed consent.

Pts w/ prior biopsy-proven low grade astrocytoma who now have a biopsy-proven anaplastic astrocytoma and have not been previously treated w/either radiation or chemotherapy

Adequate bone marrow reserve hemoglobin >/=10grams, ANC >/=1500/mm3, plt >/=150,000/mm3, liver function tests (AST/SGOT, alkaline phosphatase, total bilirubin) <2 x upper limit of normal, serum creatinine <1.5 X normal

Histologically confirmed unifocal anaplastic astrocytoma by central review or mixed oligodendroglial/astrocytic tumors where the oligodendroglial component is less than or equal to 25%.

Any pre-existing lung disease that will prevent administration or completion of therapy with BCNU.

Therapy must begin within 6 weeks after tissue diagnosis. Any pre-existing lung disease that in the investigator's opinion will prevent admin. or completion of tx with BCNU.
Exclusion Criteria:Major medical illnesses or psychiatric impairments, which the PI feels will prevent administration or completion of protocol therapy &/or interfere with follow-up.

Any oligodendroglial component > 25%.

Tumor predominately located in the posterior fossa (i.e. brainstem or cerebellum).

Spinal cord tumors.

Evidence of spinal drop metastases or spread to non-contiguous meninges.(Spinal MRI not required in asymptomatic pts;pts not excluded based on pathologic evidence of local meningeal infiltration by underlying tumor).

Prior malignancy(excluding in situ carcinoma of the cervix, or non-melanomatous skin cancer) unless disease free for at least 5 yrs.

Prior radiation to the brain or head/neck.

Prior chemotherapy.

Active infectious process.

Pregnant or nursing.

Inability or unwillingness to use effective contraception by both male and female pts.

Known or suspected hypersensitivity to one of the components of BCNU or temozolomide or to any other nitosourea or Dacarbazine.
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Links
Registration Number:
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Results

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