Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
OBJECTIVES:
Primary
- To assess whether concurrent radiotherapy with daily temozolomide improves overall
survival as compared to no daily temozolomide in patients with non-1p/19q deleted
anaplastic glioma.
- To assess whether adjuvant temozolomide improves survival as compared to no adjuvant
temozolomide in patients with non-1p/19q deleted anaplastic glioma.
Secondary
- To assess whether concurrent and adjuvant temozolomide prolongs progression-free
survival and neurological deterioration-free survival in patients with non-1p/19q
deleted anaplastic glioma.
- To assess the safety of concurrent and adjuvant temozolomide in patients with
non-1p/19q deleted anaplastic glioma, including late effects on cognition.
- To assess the impact of concurrent and adjuvant temozolomide on the quality of life of
patients with non-1p/19q deleted anaplastic glioma.
OUTLINE: This is a multicenter study. Patients are stratified according to institution, WHO
performance status (0 vs > 0), age (≤ 50 vs > 50), presence of 1p LOH only (yes vs no),
presence of oligodendroglial elements (yes vs no), and O6-methylguanine-DNA
methyltransferase promoter methylation status (methylated vs unmethylated vs indeterminate).
Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients undergo radiotherapy* once daily, 5 days a week, for 6.5 weeks (total
of 33 fractions).
- Arm II: Patients undergo radiotherapy* once daily, 5 days a week and receive oral
temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).
- Arm III: Patients undergo radiotherapy* once daily, 5 days a week for 6.5 weeks (total
of 33 fractions). Beginning 4 weeks after completion of radiotherapy, patients receive
adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide
repeats every 28 days for up to 12 courses.
- Arm IV: Patients undergo radiotherapy* once daily, 5 days a week and receive oral
temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).
Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant oral
temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every
28 days for up to 12 courses.
NOTE: *Patients must begin radiotherapy within 8 days after randomization and within 7 weeks
after surgery.
In all arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
Patients complete quality-of-life questionnaires, including QLQ-C30 version 3, BCM20, and
the Mini Mental Status Exam at baseline, 4 weeks after the completion of radiotherapy, and
then every 3 months for 5 years.
Tissue samples are collected at baseline for histology review, 1p/19q analysis, methylation
status of the O6-methylguanine-DNA methyltransferase promoter, and isocitrate dehydrogenase
mutation analysis.
After completion of study treatment, patients are followed every 3 months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival as measured from the day of randomization
No
Wolfgang Wick
Study Chair
Universitatsklinikum Heidelberg
Unspecified
CDR0000582632
NCT00626990
December 2007
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