TEMOZOLOMIDE for Diffuse low-grade glioma

Inclusion criteria

• {"criterion_text":"- Adult patient aged ≥ 18, no age limit\n- Negative pregnancy test in women of childbearing potential\n- Signature du consentement éclairé avant toute procédure de l’étude\n- Patient fluent in French\n- Patient affiliated to a French social security system\n- Histologically-proven DLGG\n- Patient receiving TMZ as a first line treatment after surgery, whatever the delay between the surgery and the introduction of TMZ\n- No previous oncologic treatment (except for surgery) for the DLGG;\n- Performance Status score ≤2\n- Absolute neutrophil count (ANC) ≥ 1500 cells/µL and platelet count ≥ 100 000 cells/µL\n- Total serum bilirubin concentration ≤ 1.5 x the upper limit of normal (UPN)\n- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 2.5 x the ULN ;\n- Serum creatine concentration ≤ 1.5 x the ULN"}

Exclusion criteria

• {"criterion_text":"- Anaplastic glioma (WHO grade III glioma)\n- 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\n- Pregnant or breastfeeding women;\n- 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;\n- Participation in another clinical trial within 30 days prior to study entry.\n- Impaired neurocognitive functioning defined by a score < 22 at the MoCA test\n- Visual or auditory deficit\n- Previous chemotherapy for the DLGG\n- Previous RT for the DLGG\n- Known hypersensitivity to any of the study drugs, or excipients in the formulation\n- Hypersensitivity to dacarbazine (DTIC);\n- Myélosuppression sévère;\n- Problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;"}

Primary endpoints

• {"endpoint_text":"- Feasability will be analyzed using two parameters: 1.participation rate: proportion of patients that consent to participate in the study among the screened patients. We expect that 80% of the sceened patients will consent to the study. 2. compliance rate: the proportion of included patients that will complete the evaluations at baseline, 6 months and 12 months. We expect that 80% of patients will be compliant.","definition_or_measurement_approach":"Feasibility assessed by two measures: (1) participation rate = proportion of screened patients who consent; (2) compliance rate = proportion of included patients completing evaluations at baseline, 6 months and 12 months. Expected rates: 80% for both."}

Secondary endpoints

• {"endpoint_text":"- The total score obtained at the EORTC QLQ-C30 and the scores obtained at the different dimensions of the QLQ-C30 (ranged from 0 to 100) according to the EORTC’s instructions;","definition_or_measurement_approach":"Total and subscale scores per EORTC QLQ-C30 scoring rules (0-100), calculated according to EORTC instructions."}
• {"endpoint_text":"- The total score obtained at the QLQ-BN20 and the scores obtained at the different dimensions of the QLQ-BN20 (ranged from 0 to 100) according to the EORTC’s instructions","definition_or_measurement_approach":"Total and subscale scores per QLQ-BN20 scoring rules (0-100), calculated according to EORTC instructions."}
• {"endpoint_text":"- Le score total obtenu au questionnaire IMF (Inventaire Multifactoriel de Fatigue)","definition_or_measurement_approach":"Total score on the MFI (Multidimensional Fatigue Inventory) as per Smets et al. (1995); translated/instrument scoring applied (score range noted in translations between 4-20 for some scales)."}
• {"endpoint_text":"- The four scores obtained at the four subscales of the french FACT-Cog (Functional Assessment of Cancer Therapy-Cognitive Function) assessing the perceived cognitive impairments (from 0 to 72), the comments from others (from 0 to 16), the perceived cognitive abilities (from 0 to 16), and the impact on quality of life (from 0 to 28);","definition_or_measurement_approach":"FACT-Cog subscale scores calculated per instrument instructions; ranges: perceived cognitive impairments 0–72, comments from others 0–16, perceived cognitive abilities 0–16, impact on QoL 0–28."}
• {"endpoint_text":"- The percentage of patients experiencing a decline in the QoL scores: decline is defined as ≥ 20% of decrease with the following calcul: [(score at baseline – score at further evaluation)/score at baseline]*100.","definition_or_measurement_approach":"Decline defined as ≥20% decrease from baseline using formula [(baseline score – later score)/baseline score]*100; percentage of patients meeting this criterion reported."}
• {"endpoint_text":"- The total score (from 0 to 50) obtained at the f-NART (French version of the National Adult Reading Test) according to the Mackinnon and Mulligan (2005)’s instructions;","definition_or_measurement_approach":"Total f-NART score (0–50) calculated according to Mackinnon & Mulligan (2005) instructions."}
• {"endpoint_text":"- The total score (from 0 to 30) obtained at the MoCA (Montreal Cognitive Assessment) according to the Nasreddine et al. (2012)’s instructions;","definition_or_measurement_approach":"Total MoCA score (0–30) calculated per Nasreddine et al. (2012) instructions; note MoCA score <22 is an exclusion criterion."}
• {"endpoint_text":"- The index of psychomotor speed (ranged from 40 to 160) according to the Wechsler (2011)’s calculation rules, which are based on the scores obtained at the Digit-symbol substitution test and the Code test of the WAIS-IV.","definition_or_measurement_approach":"Index of psychomotor speed calculated per Wechsler (2011) from WAIS-IV Digit-Symbol and Code subtests; range 40–160."}
• {"endpoint_text":"- The scores obtained at the HVLT-R (Revised Hopkins Verbal Learning Test) according to Rieu et al (2006)’s instructions: the number of correct free recalls (for each of the 3 trials), the total learned score, the number of correct delayed recalls, the recognition hits rate, the false positives rate, the discrimination rate, the number of intrusions and perseverations;","definition_or_measurement_approach":"HVLT-R metrics per Rieu et al. (2006): free recall counts per trial, total learned score, delayed recall, recognition hit rate, false positives, discrimination index, intrusions, perseverations."}
• {"endpoint_text":"- The four scores obtained at the complex Rey figure, as noticed in the instructions of Wallon and Mesmin (2009) (copy type, , timing, free immediate and delayed and recall);","definition_or_measurement_approach":"Rey Complex Figure scores (copy type, timing, immediate free recall, delayed recall) assessed per Wallon & Mesmin (2009) instructions."}
• {"endpoint_text":"- The different scores obtained at the MemProsp tasks (both event and time-based tasks) according to Einstein and Mc Daniel (1990)’s instructions: number of correct prospective memory responses, number of calls for the time counter (over the entire session and within the last 30-second before the target), number of correct word ratings.","definition_or_measurement_approach":"MemProsp prospective memory measures per Einstein & McDaniel (1990): correct prospective responses, time-counter calls, correct word ratings, etc."}
• {"endpoint_text":"- The timing (ms), the number and type of errors (flexibility, proximity or attentionnal) gathered at the TMT A and B (Trail Making Test A and B) as Ashendorf et al. (2008) and Godefroy et al. (2010) described in their instructions;","definition_or_measurement_approach":"TMT A and B metrics: completion time (ms), number and type of errors per Ashendorf et al. (2008) and Godefroy et al. (2010)."}
• {"endpoint_text":"- The timing (ms), the total number of omissions (from 0 to 35), and the difference between left omissions and right omissions gathered at the Bell’s test, according to the Rousseaux et al. (2001)’s instructions;","definition_or_measurement_approach":"Bell's test metrics: timing (ms), total omissions (0–35), left vs right omission difference per Rousseaux et al. (2001)."}
• {"endpoint_text":"- The number and percentage of patients who report high-grade (grade 3-4-5 according to the CTCAE-NCI criteria) adverse reactions of interest will be summarized for all treated patients;","definition_or_measurement_approach":"Number and percentage of patients with CTCAE NCI grade 3–5 adverse events summarized for all treated patients."}
• {"endpoint_text":"- The Objective Response Rate (ORR), defined as the number and percentage of patients with a best overall response of complete response (CR) or partial response (PR) recorded between the date of first dose of TMZ and the date of the objectively documented tumor progression according to the RANO criteria (van den Bent et al., 2011) in all treated patients","definition_or_measurement_approach":"ORR per RANO criteria: proportion of patients achieving CR or PR between first dose and documented progression."}
• {"endpoint_text":"- The proportion of patients experiencing a decrease of their tumor volume under TMZ. The tumor volume (cm3), determined on the T2/FLAIR sequence of the brain MRI (in DICOM format) using manual delineation of the tumor limits on each slide and calculation of the volume on a dedicated software;","definition_or_measurement_approach":"Proportion with tumor volume decrease measured (cm3) on T2/FLAIR MRI using manual delineation on DICOM and dedicated software."}
• {"endpoint_text":"- The PFS, defined as the delay between the date of introduction of TMZ and the date of the progression (according to the RANO criteria) or death from any cause;","definition_or_measurement_approach":"PFS defined as time from TMZ start to progression per RANO or death from any cause."}
• {"endpoint_text":"- The OS, defined as the delay between the date of introduction of TMZ and death from any cause.","definition_or_measurement_approach":"OS defined as time from TMZ start to death from any cause."}

France

Earliest CTIS Part Ii Submission Date

07-08-2024

Latest Decision Or Authorization Date

19-09-2024

Processing Time Days

43

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Institut Regional Du Cancer De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France