| Titre |
Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma |
| Protocole ID |
BN001 |
| ClinicalTrials.gov ID |
NCT02179086 |
| Type(s) de cancer |
Cerveau (SNC) |
| Phase |
Phase II |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 L'HOTEL-DIEU DE QUEBEC ET CRCEO
11 Côte du Palais, Québec, QC, G1R 2J6
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dre Nathalie Lessard
|
| Coordonnateur(trice) |
Josée Allard
418-525-4444 poste 16730
|
| Statut |
 Actif en recrutement |
| Date d'activation |
18-02-2015 |
| Critètes d'éligibilité |
-
A diagnostic contrast-enhanced magnetic resonance imaging (MRI) (no other scan type allowed) of the brain must be performed postoperatively within 72 hours of resection; the enhancing tumor must have a maximal diameter of 5 cm; the tumor diameter will be the greatest diameter as measured on the contrast-enhanced postoperative MRI and will include residual disease and/or the postoperative surgical cavity as appropriate; for cases where residual disease or postoperative surgical cavity is NOT identifiable (e.g., polar glioblastomas [GBMs] where a polar lobectomy is performed), the patient will be excluded from the trial
-
The GBM tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)
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Histologically proven diagnosis of glioblastoma (World Health Organization [WHO] grade IV) confirmed by central review
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Tumor tissue that is determined by central pathology review registration to be of sufficient quantity for analysis of O6-methylguanin-DNA-methyltransferase (MGMT) status
-
Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged to maximize the chances of eligibility; at least 1 cubic centimeter of tissue composed primarily of tumor must be present
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Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy or cavitron ultrasonic suction aspirator (CUSA) technique are not allowed
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History/physical examination within 14 days prior to registration
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The patient must have recovered from effects of surgery, postoperative infection, and other complications within 14 days prior to registration
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Documentation of steroid doses within 14 days prior to registration
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Karnofsky performance status >= 70 within 14 days prior to registration
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Age >= 18
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Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
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Platelets >= 100,000 cells/mm^3
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Hemoglobin >= 10.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)
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Bilirubin =< 1.5 upper limit of normal (ULN)
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Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
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CD4 lymphocyte count within 14 days prior to registration
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Negative serum pregnancy test obtained for females of child-bearing potential within 14 days prior to registration
|
| Critètes d'exclusion |
-
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
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Recurrent or multifocal malignant gliomas
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Any site of distant disease (for example, drop metastases from the GBM tumor site)
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Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide)
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Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
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Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
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Severe, active co-morbidity, defined as follows:
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Unstable angina
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Transmural myocardial infarction within the last 6 months
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Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG)
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New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
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Serious and inadequately controlled arrhythmia
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Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection
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Acute bacterial or fungal infection requiring intravenous antibiotics
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Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
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Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
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Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
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Any other severe immunocompromised condition
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Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
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End-stage renal disease (ie, on dialysis or dialysis has been recommended)
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Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy
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Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
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Patents treated on any other therapeutic clinical protocols within 30 days prior to registration
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Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker, or severe claustrophobia)
|
Groupe d'étude en oncologie du Québec