Status:
COMPLETED
Quality of Life and Neurocognitive Functioning
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Studying QoL in patients DLGG receiving TMZ is complex because of the multiples interactions between tumor characteristics, neurocognitive functioning, treatments, environment and psychopathological c...
Detailed Description
Diffuse low-grade gliomas (DLGG) (or WHO grade II gliomas, Louis et al., 2007) are rare tumors, with an incidence estimated at 1/105 person-year (Ostrom et al., 2015). They affect young people in thei...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03257618
Start Date
July 27 2017
End Date
December 31 2021
Last Update
January 11 2022
Active Locations (1)
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1
Institut regional du Cancer - Val d Aurelle
Montpellier, France, 34298