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Quality of life and neurocognitive functioning in diffuse low-grade glioma patients treated with Temozolomide: feasibility study - TEMOIN
EU CTIS ID: 2024-516918-37-00
What this study is testing
This study will evaluate the feasability in terms of participation and compliance of a complete neurocognitive, psychopathological and QoL assessment (baseline, 6 months and 12 months) in DLGG patients receiving TMZ as a first line treatment after surgery. The data collected in this feasability study will be used to formulate hypotheses for a future multicentric clinical study.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient aged ≥ 18, no age limit
- Negative pregnancy test in women of childbearing potential
- Signature du consentement éclairé avant toute procédure de l’étude
- Patient fluent in French
- Patient affiliated to a French social security system
- Histologically-proven DLGG
You likely can't join if
- Anaplastic glioma (WHO grade III glioma)
- 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 within 30 days prior to study entry.
- Impaired neurocognitive functioning defined by a score < 22 at the MoCA test
See the full eligibility criteria
- Adult patient aged ≥ 18, no age limit
- Negative pregnancy test in women of childbearing potential
- Signature du consentement éclairé avant toute procédure de l’étude
- Patient fluent in French
- Patient affiliated to a French social security system
- 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 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 (UPN)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 2.5 x the ULN ;
- Serum creatine concentration ≤ 1.5 x the ULN
- Anaplastic glioma (WHO grade III glioma)
- 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 within 30 days prior to study entry.
- Impaired neurocognitive functioning defined by a score < 22 at the MoCA test
- 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);
- Myélosuppression sévère;
- Problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.