Clinical Trial Details
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NCT03257618 : Quality of Life and Neurocognitive Functioning
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Adult patient aged = 18, no age limit;

- Histologically-proven DLGG;

- Patient receiving TMZ as a first line treatment after surgery, whatever the delay
between the surgery and the introduction of TMZ;

- No previous oncologic treatment (except for surgery) for the DLGG;

- Performance status (PS) score = 2;

- Absolute neutrophil count (ANC) = 1500 cells/µL and platelet count = 100 000 cells/µL;

- Total serum bilirubin concentration = 1.5 x the upper limit of normal (ULN);

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline
phosphatase = 2.5 x the ULN;

- Serum creatine concentration = 1.5 x the ULN;

- Negative pregnancy test in women of childbearing potential;

- A signed informed consent obtained before any study specific procedures;

- Patient fluent in French ;

- Patient affiliated to a French social security system

Exclusion Criteria:

- Anaplastic glioma (WHO grade III glioma);

- Impaired neurocognitive functioning defined by a score < 22 at the MoCA evaluation;

- Visual or auditory deficit ;

- Previous chemotherapy for the DLGG;

- Previous RT for the DLGG;

- Known hypersensitivity to any of the study drugs, or excipients in the formulation;

- Hypersensitivity to dacarbazine (DTIC);

- Severe myelosuppression;

- Problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose

- Legal incapacity or physical, psychological social or geographical status interfering
with the patient's ability to sign the informed consent or to terminate the study;

- Pregnant or breastfeeding women;

- Men or women of childbearing potential who are unwilling to employ adequate
contraception, from the beginning of the study until 6 months after administration of
the last treatment dose;

- Participation in another clinical trial with 30 prior to study entry.
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