An interventional study of Temozolomide and QoL, neurocognitive and psycholpathological assessment in Glioma, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Treatment
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.
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 their thirties or forties (Capelle et al., 2013). DLGG are characterized by a continuous growth and an unavoidable anaplastic transformation (Mandonnet et al., 2003). Epilepsy is the main presenting mode while neurological deficits are rare at diagnosis due to the brain plasticity allowed by the usually slow growth speed of these tumors. However, frequent alterations in cognitive functions (including mostly memory, executive functioning, and attention) have been described (Racine et al., 2015). The prognosis of DLGG is variable (Pignatti et al., 2002) and overall survival (OS) ranges from 5 years to 15 years according to several factors, including the tumor phenotype, the isocitrate dehydrogenase (IDH) mutation and the 1p19q codeletion, the tumor volume at diagnosis, and the tumor spontaneous growth speed (Capelle et al., 2013).
The prognostic impact of the extent of surgery has now been well demonstrated (Jakola et al., 2012; Duffau 2016) and surgery is now the first treatment option (Soffietti et al., 2010). In unresectable DLGG or in patients with a progressive disease after surgery (with no possibility of a second surgery), several treatment options have been investigated, including radiation therapy (RT) and chemotherapy, but to date the timing and choice of treatment remains controversial. RT can be efficient in DLGG, however, the EORTC 22845 phase III trial found that early RT has no impact on OS compared to late RT, despite an increased progression-free survival (PFS) (van Den Bent et al., 2005). Moreover, some evidence of late decreased neurocognitive functioning has been consistently reported following RT (Klein et al., 2002; Douw et al., 2009). Because of this potential neurotoxicity and the absence of a benefit on OS of early RT, many neuro-oncological teams now only offer RT to patients with a progressive disease after chemotherapy.
Temozolomide (TMZ), an orally administered drug, was shown to be efficient in DLGG, with a good tolerance (Hoang-Xuan et al., 2004; Ricard et al., 2007). However, data regarding the impact of TMZ on neuro-cognitive functioning and quality of life (QoL) are scarce. Only few studies have performed an extensive, longitudinal assessment of cognition and QoL in DLGG patients receiving TMZ (Liu et al., 2009; Blonski et al., 2012; Klein, 2015). Moreover, many studies did not take into account the other factors that can alter the cognition such as the tumor itself, the surgery, seizures, anti-epileptic drugs, but also the premorbid level of cognition and the psychopathological affects such as depression, anxiety, or anger (Klein, 2015). To date, there is only few data on these psychopathological aspects in DLGG patients, either at diagnosis or following chemotherapy or RT.
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.
1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.
This study's enrollment of 26 is below the median of 32 across 1,075 interventional studies indexed under Glioma.
Browse Glioma studies →Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 142 studies on the registry; 47 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with TMZ will be given orally according to standard practices. The therapeutic schedule will be left at the investigator's discretion. Patients will be followed every 3 months during the treatment period, at the end of the treatment with TMZ, 6 months after the end of TMZ, and then annually until tumor progression.
Drug: Temozolomide · Other: QoL, neurocognitive and psycholpathological assessment
Treatment with TMZ will be given orally according to standard practices. The therapeutic schedule will be left at the investigator's discretion. Patients will be followed every 3 months during the treatment period, at the end of the treatment with TMZ, 6 months after the end of TMZ, and then annually until tumor progression.
This assessment will be performed at baseline, at 6 months, 12 months, 18 months, at the end of the treatment with TMZ, 6 months after the end of TMZ
proportion of patients that consent to participate in the study
The participation rate: the proportion of patients that consent to participate in the study among the screened patients.
Time frame: through study completion, an average of 5 year
proportion of included patients that will complete the evaluations at baseline, 6 months and 12 months
proportion of included patients that will complete the evaluations at baseline, 6 months and 12 months
Time frame: through study completion, an average of 5 year
Plan to share: Undecided
Ran from Jul 2017 to primary completion in Nov 2021, 51 months.
Of 131 non-industry interventional studies with no phase under Glioma, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 114. This study's 51 months is below that.
Counting every sponsor, half of 142 studies reached it within 58 months; a quarter within 34 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Temozolomide
Institut du Cancer de Montpellier - Val d'Aurelle →