Quality of Life and Neurocognitive Functioning

NCT03257618 | Completed

• 1 other identifier: ICM-URC2016-32
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  through study completion, an average of 5 year

Study Arms (1)

Temozolomide

EXPERIMENTAL

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

Interventions

QoL, neurocognitive and psycholpathological assessment OTHER

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

Temozolomide

Temozolomide DRUG

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.

Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut regional du Cancer - Val d Aurelle

Montpellier, 34298, France

Location

Related Publications (1)

• Darlix A, Monnier M, Castan F, Coutant L, Fabbro M, Denis-Chammas E, Carriere M, Menjot-de-Champfleur N, Rigau V, Duffau H, Guerdoux E. Longitudinal assessment of quality of life, neurocognition, and psychopathology in patients with low-grade glioma on first-line temozolomide: A feasibility study. Neurooncol Adv. 2024 Jun 4;6(1):vdae084. doi: 10.1093/noajnl/vdae084. eCollection 2024 Jan-Dec.

  PMID: 38946878 RESULT

MeSH Terms

Conditions

Glioma

Interventions

Temozolomide; Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• jean pierre bleuse

  Institut régional du Cancer de Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: July 27, 2017
• Primary Completion: November 26, 2021
• Study Completion: December 31, 2021
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)