TITRE |
Étude intergroupe de la phase III portant sur la combinaison radiothérapie et témozolomide concomitant et adjuvant par rapport à une chimiothérapie PCV adjuvante administrée à des patients qui ont un gliome anaplasique ou de bas grade avec la codélétion 1p/19q. |
PROTOCOLE ID |
CEC.6 |
CLINICAL TRIAL.gov ID |
NCT00887146 |
TYPE(S) DE CANCER |
Cerveau (SNC) |
PHASE |
Phase III |
TYPE D'ÉTUDE |
Traitement |
INSTITUTION |
CHUM
1051 rue Sanguinet
(514) 890-8000
|
VILLE |
Montréal
|
INVESTIGATEUR(RICE) PRINCIPAL(E) |
Laura Masucci
|
COORDONATEUR(RICE) |
Diane Trudel diane.dt.trudel.chum@ssss.gouv.qc.ca 514-890-8000 poste 11181
|
STATUT |
Fermé
|
CRITÈRES D'ÉLIGIBILITÉ |
(EN)
|
CRITÈRES D'EXCLUSION |
(EN)
- Fetal/Newborn Toxicity: Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects: Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of temozolomide treatments.
- Received any prior surgery, radiation therapy or chemotherapy for any central nervous system (CNS) neoplasm. Note: Patients who have had a prior low grade glioma with or without surgery and who now have anaplastic glioma with no prior radiation or chemotherapy are eligible for the study.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study.
- Patients known to be Human Immunodeficiency Virus (HIV) positive and currently receiving retroviral therapy. Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
-
Other active malignancy within 5 years of registration. Exceptions:
Non-melanotic skin cancer or carcinoma in situ of the cervix. Note: If there is a history of prior malignancy, the patient must not be receiving other specific treatment (other than hormonal therapy) for their cancer.
- History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
- Recent history of hepatitis infection or treating physician determined that the patient would be at significant risk of reactivation of hepatitis.
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