Quality of Life and Neurocognitive Functioning

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Studying QoL in patients DLGG receiving TMZ is complex because of the multiples interactions between tumor characteristics, neurocognitive functioning, treatments, environment and psychopathological context in which these patients experience symptoms. It is, however, important to accurately evaluate these aspects in consideration of the young age, generally preserved QoL at the time of diagnosis, possible implications of the disease on the professional (DLGG patients are often still active), social and familial domain, and relatively long survival of these patients. In the absence of a curative treatment for DLGG, preserving patients' QoL is indeed a major goal.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Treatments: Temozolomide

Criteria

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 malabsorption;

• 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.