Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma

Léon Bérard Center

Status: Terminated

Conditions: OMS Grade II Glioma

Treatments: Behavioral: neurocognitive tests

Study type: Interventional

Funder types: Other

Identifiers

NCT01305122

TUMEURS GLIALES

Details and patient eligibility

About

This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II glioma will be followed during 5 years.

• cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy)
• cohort B: patients with disease simple monitoring.

The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive functions and quality of life, using validate and standard tests.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OMS grade II glioma
• signed informed consent
• age >=18
• IK >=80%
• ability to read, write and undertand French

Exclusion criteria

• glioma localized to brainstem
• other neurologic or psychiatric disease
• history of other malignancies, other than curatively treated in-situ carcinoma of the cervix or basal cell carcinoma of the skin, or any other curatively treated cancer with no sign of recurrence within 5 years prior to randomization
• neuroleptic concomitant treatment
• pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

OMS grade II glioma

Other group

Description:

neurocognitive tests

Treatment:

Behavioral: neurocognitive tests