Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non - 1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.
The goal of the screening consent is to learn if you are eligible to take part in the main research study. The goal of the clinical research study is to learn if giving temozolomide in combination with radiation therapy can help to control anaplastic glioma for a longer time than standard radiation therapy alone. The safety of this combination treatment will also be studied.
Disease Group: Brain
Treatment Agent: Temozolomide
Treatment Location: Both at MD Anderson & Other Sites
Sponsor: NRG Oncology/CTSU and EOTRC
1. Primary objectives To assess whether concurrent radiotherapy(RT) with daily temozolomide(TMZ) 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 2. 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.
IRB Review and Approval Date: 06/18/2010
Recruitment Status: Closed
Projected Accrual: 1360
1) Histologically confirmed newly diagnosed anaplastic
oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma
by local diagnosis (at the time of registration)
2) Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review.
3) Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
4) WHO performance status 0-2
5) Age >/= 18 years
6) All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding
7) Before patient registration, written informed consent must be obtained, according to ICH/GCP, and national/local regulations.(at the time of registration)
8) The combination of : 1) Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis, AND 2) Absence of combined 1p/19q loss. Both of which must have been determined by either local testing or central review ( at randomization step)
9) Start of radiotherapy within 8 days from randomization (at randomization step)
10) Start of radiotherapy within 7 weeks (49 days) from surgery (extra 2 days could be allowed) (at randomization step)
11) Patients must be on a stable or decreasing dose of steroids for at least two weeks (at randomization step)
12) Adequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 28 days prior to randomization): 1) neutrophils greater or equal to 1.5*10^9 cells/l. 2) platelets greater or equal to 100*10^9 cells/l. 3) bilirubin < 1.5 times upper limit of laboratory normal. 4) alkaline phosphatase, ASAT and ALAT <2.5 times upper limit of laboratory normal. 5) serum creatinine lower than 1.5 times upper limit of laboratory normal. Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable.(at randomization step)
13) Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.(at randomization step)
1) Known HIV infection, chronic hepatitis B or hepatitis C infection
2) Any other serious medical condition that can interfere with follow-up
3) Any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
4) No previous other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to registration, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix.
5) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
6) Prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel®)
7) Prior radiotherapy to the brain
8) No concomitant treatment with other anti-cancer agents or with any other experimental agent (at randomization step)