Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT03257618
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03257618
Study Brief:
Protocol Section:
NCT03257618