Clinical trial NCT01305122: Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma
Official title: Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma: Multicentric Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: OMS Grade II Glioma
Keywords: Glioma
Neurocognitive functions
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-02-28
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: MoCA test
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CH Amiens-Picardie
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: BESANCON Cedex
country: France
facility: Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Hôpital Saint André
city: DIJON Cedex
country: France
facility: Centre Georges François Leclerc
city: LILLE Cedex
country: France
facility: Centre Oscar Lambret
city: LILLE Cedex
country: France
facility: CHRU de Lille
city: LYON Cedex 03
country: France
facility: Hôpital d'instruction des armées Desgenettes
city: LYON Cedex 08
country: France
facility: Centre Léon Bérard
city: MONTPELLIER Cedex 5
country: France
facility: Hôpital Guy de Chauliac
city: NANCY Cedex
country: France
facility: Hôpital Central de Nancy
city: NICE Cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Hôpital Pasteur
city: PARIS Cedex 13
country: France
facility: Hôpital Pitié Salpêtrière
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: REIMS Cedex
country: France
facility: Hôpital Maison Blanche
city: ROUEN Cedex 1
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: CHU Charles NICOLLE
city: Saint Herblain
country: France
facility: Centre René Gauducheau
city: Valenciennes
country: France
facility: CH Valenciennes
city: VANDOEUVRE LES NANCY Cedex
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Léon Bérard, Lyon - FRANCE
name: Marie-Pierre SUNYACH, MD
role: PRINCIPAL_INVESTIGATOR
References: