Protocol Summary

Protocol No.: OCR14992

Sponsor Protocol No.: N0577

Study Title
Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Principal Investigator(s)
Tran, David

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Phase: Phase III

Age Group: Adult

Scope: National

Arm A - Radiotherapy followed by PCV
Patients undergo radiotherapy (RT) 5 days per week for about 6-7 weeks. (Cycle 1 is about 6 to 7 weeks). Cycle 2 rest period is about 4 weeks. Patients receive PCV chemotherapy for about 6-7 weeks, a total of 6 cycles.

Arm B - Radiotherapy + TMZ followed by TMZ
Patients undergo radiotherapy (RT) and temozolomide (TMZ) treatment for 5 days per week for about 6-7 weeks (Cycle 1). Cycle 2 rest period is about 4 weeks. Patients receive adjuvant temozolomide for about 4 weeks, a total of 6 cycles. TMZ may be extended to 12 cycles if the patient shows acceptable tolerance and no evidence of progression.

Detailed Eligibility
1. Ages 18 years old and older
2. Newly diagnosed and =Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade 2 or 3] or low grade glioma [WHO grade 2], as determined by pre-registration central pathology review. Note: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q.
3. Patients with codeleted low grade gliomas must also be considered "high risk" by clinical criteria utilized in RTOG 9802 and must be either: age >= 40 and any surgical therapy or age 4. Tumor tissue must show co-deletion for the relevant portions of chromosomes 1p and 19q by FISH analysis, as defined by the testing laboratory.
5. Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration. Patient must have recovered from the effects of surgery.

* Contact study team for complete eligibility details

Applicable Disease Sites
Brain and Nervous System

Participating Institutions
UF Gainesville : Sarah Andrews

Sarah Andrews, RN


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