Cleveland Clinic Brain Tumor and Neuro-Oncology Center Clinical ...

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Cleveland Clinic Brain Tumor and Neuro-Oncology Center:Patient Data http://bti.ccf.org/cgi-bin/bti/auth/detailLAMINATE.cgi?id=613 Page 4 of 4 4/11/2013 ◦ platelets greater or equal to 100*10 9 cells/l ◦ bilirubin < 1.5 times upper limit of laboratory normal ◦ alkaline phosphatase, ASAT and ALAT < 2.5 times upper limit of laboratory normal ◦ serum creatinine lower than 1.5 times upper limit of laboratory normal • All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding • Absence of known HIV infection, chronic hepatitis B or hepatitis C infection • Absence of any other serious medical condition that could interfere with follow-up • Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction) • Absence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in situ of te cervix and non-melanoma skin cancer. • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. • Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Patients can only be randomized in this trial once.
Cleveland Clinic Brain Tumor and Neuro-Oncology Center:Patient Data http://bti.ccf.org/cgi-bin/bti/auth/detailLAMINATE.cgi?id=613 Page 1 of 4 4/11/2013 Cleveland Clinic Brain Tumor and Neuro-Oncology Center Clinical Database Open Clinical Protocols Information CCF IRB CC945 RTOG 0834 Full Title P.I. Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial. Samuel Chao, M.D. Primary objectives • To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma. • To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in patients with non-1p/19q deleted anaplastic glioma Objectives Secondary objectives • To assess whether concurrent and adjuvant temozolomide treatment 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 treatment on the quality of life in patients with non-1p/19q deleted anaplastic glioma.
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