Brain Disease Site Listings - Public Select Disease Site All Brain Breast Gastro-Intestinal Genito-Urinary Gynecologic Head & Neck Hematologic IND Lung Melanoma Multi-Site Sarcoma Symptom Control IDSort Study Title Status Sort CE7 (CE.7)A Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain MetastasesThe purpose of this research study is to compare the effects (good or bad) of receiving stereotactic radiosurgery (SRS) versus receiving whole brain radiation therapy (WBRT) plus a drug called memantine, on brain metastases. Receiving SRS could control cancer that has spread to the brain. Read More Complexity Level: 2Eligibility: - Patient must have 5 or more brain metastases by MRI obtained within 30 days of enrollment. Largest brain metastasis must be <2.5cm, and total tumour volume must be 30cm3 or less - Patient must be willing and able to complete QoL questionnaires, neurocognitive assessments, and must agree to use effective contraception if of child bearing potential - Centre must be IROC credentialied and able to treat patients using an SRS system or HA-WBRT - Patient must have a pathological diagnosis of a non-hematopoietic malignancy - Patient must be >18 years old, ECOG 0-2, and creatinine clearance of 30ml/min or more Objectives: Primary Endpoints: - Overall Survival and neurocognitive PFS Secondary Endpoints: - time to CNS failure; difference in CNS failure patterns;number of salvage procedures following SRS; cognitive tests; adverse events; time delay to re-initiation of systemic therapy post treatment; validate nomogram; Health Economics; Quality of Life; Correlative Studies; Imaging data collection and evaluationNCT Registration ID (from clinicaltrials.gov): NCT03550391Participation: Open to member centresNCI US Affiliation: YesClinical Trials Application (Canada): YesCoordination: CCTG Led TrialStatus: Open to AccrualActivation Date: May 25, 2018Chair: (Canada) Dr. David Roberge, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8254, (USA) Dr. Michael Chan, Wake Forest School of Medicine, (336) 713-3600Open to AccrualCE9 (LUMOS2)Low and Anaplastic Grade Glioma Umbrella Study of Molecular Guided Therapies (LUMOS2)Cancers of the brain are very serious, difficult to treat, and frequently lead to death. Patients with a specific type of brain cancer called grade 2 or grade 3 glioma may live for some time following initial treatment, but when the cancer comes back, it can behave similarly to the most aggressive brain tumours and not respond to the limited treatments that are available. We propose to study this group of patients in a clinical trial using new treatments. We will perform molecular analysis to identify the underlying problem of the cells in the tumour and provide treatment for that specific molecular abnormality. Patients without a molecular change identified will receive new but less specific treatment. We will follow these patients to see if the new treatments are effective. Specifically, we will look to see how many patients have their tumours increase in size or spread within the first six months, how long patients live, how often the disease responds to treatment, what is the quality of life for the patient, what is the safety and tolerability of the treatment, and whether we can determine the specific reason the treatment did or did not work using additional molecular analysis. If these new treatments are found to be possibly effective, we plan to develop future clinical trials to confirm they work in a larger study. Read More Complexity Level: 2Eligibility: Adults, aged 18 years and older Histologically confimed glioma IDH-mutant, histologically grade 2 or 3 at initial diagnosis (i.e., without necrosis or microvascular proliferation); including CDKN2A/B homozygous deleted IDH-mutant astrocytomas but not IDH-wildtype diffuse astrocytomas with any of TERT promoter mutation, EGFR amplification and/or +7/-10 copy number changes (i.e., molecular features of glioblastoma). Has evidence of progressive disease (defined as new contrast-enhancing tumour and/or 25% increase in the size of the T2/FLAIR area compared to prior imaging after prior treatment with radiotherapy and chemotherapy; with a clinical indication for neurosurgery). One prior treatment with radiotherapy and alkylating chemotherapy, defined as either sequential therapy with CNS radiotherapy then an alkylating agent, or concurrent CNS radiotherapy with an alkylating agent. ECOG performance status 0-2. Willing and able to comply with all study requirements, including treatment, timingObjectives: The primary objective of the study is to determine progression-free survival at six months (PFS6) The seondary objectives are to evaluate overall survival, response rate and health-related quality of life The tertiary objectives are to explore biomarkers associated with treatment sensitivity and resistance and conduct translational research to better understand the biology of recurrent G2/3, IDH-mutant glioma as well as Health economic analysis relating to the use of targeted or novel treatments in recurrent G2/3, IDH-mutant glioma. Participation: Open to member centresNCI US Affiliation: NoClinical Trials Application (Canada): YesCoordination: Intergroup Led TrialStatus: Open to AccrualActivation Date: June 19, 2024Chair: (Canada) Dr. Marshall W. Pitz, CancerCare Manitoba, (204) 787-8642Open to AccrualCEC1 (EORTC 26053_22054)Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial. Read More Complexity Level: 2Eligibility: Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosisObjectives: To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma. To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in patients with non-1p/19q deleted anaplastic glioma.NCT Registration ID (from clinicaltrials.gov): NCT00626990Participation: Open to member centresNCI US Affiliation: YesClinical Trials Application (Canada): YesCoordination: Intergroup Led TrialStatus: Closed to AccrualActivation Date: July 22, 2009 Closing Date: September 15, 2015Chair: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277Closed to AccrualCEC2 (NCCTG N0577)Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma Read More Complexity Level: 2Eligibility: Pre-registration . Inclusion Criteria - Willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. It should be initiated as soon after surgery as possible. Inclusion Criteria >18 years of age; Newly diagnosed and .3 months from surgical diagnosis; Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade III]), as determined by pre-registration central pathology review, and tumor is also co-deleted for 1p and 19q. NOTE: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q; 3.24 Surgery .2 weeks prior to registration must have recovered from the effects of surgery; The following laboratory values obtained 21 days prior to registration. . ANC .1500; . PLT .100,000; . Hgb>9; Total bilirubin .1.5 x UNL; SGOT (AST) .3 x UNL; Creatinine .1.5 x ULN Objectives: Survival; Progression Free Survival; Quality of Life; Cognitive Function; Correlative Biology.NCT Registration ID (from clinicaltrials.gov): NCT00887146Participation: Open to member centresNCI US Affiliation: YesClinical Trials Application (Canada): YesCoordination: Intergroup Led TrialStatus: Closed to AccrualActivation Date: July 28, 2010 Closing Date: January 14, 2015Closed to AccrualCEC6 (ALLIANCE N0577)Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma Read More Complexity Level: 2Eligibility: Pre-registration - Inclusion Criteria Willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. Registration Inclusion Criteria >18 years of age; Newly diagnosed and <3 months from surgical diagnosis; Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade 2 or 3]) or low grade glioma (WHO grade 2), as determined by pre-registration central pathology review, and tumor is co-deleted for 1p and 19q. NOTE: Mixed gliomas are eligible. Patients with codeleted low grade gliomas must also be considered "high risk." Tumor tissue must show co-deletion of chromosomes 1p and 19q by FISH analysis. Surgery must be performed >2 weeks prior to registration. Patient must have recovered from the effects of surgery; The following laboratory values obtained <21 days prior to registration: ANC>1500/mm^3; PLT>100,000/mm^3; Hgb>9 g/dL; Total bilirubin<1.5 x UNL; SGOT (AST)<3 x UNL; Creatinine<1.5 x ULNObjectives: To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide have a marginally better progression free survival as compared with patients who receive radiotherapy followed by PCV.NCT Registration ID (from clinicaltrials.gov): NCT00887146Participation: Open to member centresNCI US Affiliation: YesClinical Trials Application (Canada): YesCoordination: Intergroup Led TrialStatus: Closed to AccrualActivation Date: March 22, 2016 Closing Date: June 10, 2024Chair: (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, (403) 944-1260Closed to AccrualCEC7 (ALLIANCE A071801)Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease Read More Complexity Level: 2Eligibility: This study will recruit patients 18 years or older with Karnofsky PS => 60 who have one non-CNS primary brain metastasis completely resected <= 30 days prior to registration measuring 2 cm or larger with resection cavity < 5.0 cm. At the time of screening, patients must have 3 or fewer unresected brain metastases (<4.0 cm). Patients must be able to complete an MRI of the head with contrast, have no evidence of leptomeningeal metastasis, may not have a primary germ cell tumor, small cell carcinoma, or lymphoma, and no prior whole brain radiation therapy. Past radiosurgery to other lesions is allowed, with exceptions. Brain metastasis must be located => 5 mm of the optic chiasm and outside the brainstem. No resection of more than one brain metastasis.Objectives: The primary objective is to ascertain if time to surgical bed failure is increased with FSRS compared to SSRS in patients with resected brain metastasis. Secondary objectives include: emotional well-being at 9 months, overall survival, overall quality of life (QOL), functional independence, descriptively compare the post-treatment adverse events associated with the interventions, rates of radiation necrosis at 12 months, CNS failure patterns (local, distant brain failure, local leptomeningeal disease, widespread leptomeningeal disease), time to WBRT, emotional well-being and overall QOL in long-term survivors, time to surgical bed failure, and cognitive progression between FSRS and SSRS groups.NCT Registration ID (from clinicaltrials.gov): NCT04114981Participation: Open to member centresNCI US Affiliation: YesClinical Trials Application (Canada): NoCoordination: Intergroup Led TrialStatus: Closed to AccrualActivation Date: May 22, 2020 Closing Date: October 14, 2022Chair: (Canada) Dr. Jeffrey Greenspoon, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495Closed to AccrualCE1NCIC Cooperative Clinical Trial on Treatment of Cerebral Tumours (Glioblastomas) With Pre-Operative BCNU and Superfractionated Radiotherapy Read More NCT Registration ID (from clinicaltrials.gov): no NCTNCI US Affiliation: NoClinical Trials Application (Canada): NoCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: May 05, 1980 Closing Date: December 15, 1981Permanently ClosedCE3 (26981-22981)A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme Read More Eligibility: Patients with histologically confirmed newly diagnosed glioblastoma multiforme who have not received prior chemotherapy or radiotherapy; 18 to 70 years of age; WHO performance status < 2; stable, non-increasing dose of corticosteroids; adequate blood counts, liver and kidney function.Objectives: The primary objective of the trial is to test the efficacy of administration of temozolomide as a concomitant and adjuvant treatment to radiotherapy with respect to overall survival compared to radiotherapy alone. The secondary objectives are to compare the two treatment arms with respect to toxicity profile, progression free survival and quality of life.NCT Registration ID (from clinicaltrials.gov): NCT00006353Participation: Open to member centresNCI US Affiliation: NoClinical Trials Application (Canada): YesCoordination: Intergroup Led TrialStatus: Permanently ClosedActivation Date: May 29, 2000 Closing Date: March 22, 2002Permanently ClosedCE4 (26021)Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-Radical Surgery for Benign Intracranial Meningiomas: a Phase III Study. Read More NCT Registration ID (from clinicaltrials.gov): NCT00104936Participation: Open to member centresNCI US Affiliation: NoClinical Trials Application (Canada): NoCoordination: Intergroup Led TrialStatus: Permanently ClosedActivation Date: September 29, 2005 Closing Date: October 23, 2006Permanently ClosedCE6 (CE6)A Randomized Phase III Study of Temozolomide and Short-Course Radiation vs. Short-Course Radiation Alone in the Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients. Read More Complexity Level: 2Eligibility: Patients 65 years of age or older, with newly diagnosed, histopathologically confirmed, glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide.Objectives: PRIMARY: To compare the overall survival (OS) rates between short-course radiation therapy alone and short-course radiation therapy given together with concurrent and adjuvant temozolomide, in elderly (65 years of age or older) patients with newly diagnosed glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide. SECONDARY: To compare progression-free survival (PFS) between the two arms; To compare the nature, severity, and frequency of adverse events between the two arms; To compare the quality of life between the two arms using the EORTC QLQ-C30 and the EORTC Brain Cancer Module (QLQ-BN20); To conduct molecular correlative studies (mandatory: MGMT promoter status; optional: tissue banking).NCT Registration ID (from clinicaltrials.gov): NCT00482677Participation: Open to member centresNCI US Affiliation: NoClinical Trials Application (Canada): NoCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: May 01, 2007 Closing Date: October 01, 2013Permanently ClosedI109NCIC CTG Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma Read More NCT Registration ID (from clinicaltrials.gov): NCT00003372NCI US Affiliation: NoClinical Trials Application (Canada): YesCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: December 08, 1997 Closing Date: April 20, 2000Permanently ClosedI13NCIC CTG Phase II Study of N-methylformamide in Glioma Read More NCT Registration ID (from clinicaltrials.gov): no NCTNCI US Affiliation: YesClinical Trials Application (Canada): NoCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: December 01, 1984 Closing Date: April 29, 1985Permanently ClosedI139A Phase II Study of T138067-Sodium in Patients With Malignant Glioma Read More Eligibility: Histologically proven malignant glioma (glioblastoma multiforme or anaplastic astrocytoma). Recurrent or progressive disease following primary surgery and radiation treatment. Up to ONE prior chemotherapy regimen in the adjuvant setting, no chemotherapy for recurrence. Stable dose of steroid for > 14 days prior to registration.Objectives: To determine the efficacy and toxicity of T138067-sodium in patients with recurrent malignant glioma when given as a weekly 3-hour infusion. To determine the pharmacokinetics of T138067-sodium in a subset of patients (6) enrolled on this study.NCT Registration ID (from clinicaltrials.gov): no NCTNCI US Affiliation: NoClinical Trials Application (Canada): YesCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: November 08, 2000 Closing Date: January 09, 2002Permanently ClosedI142A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma Read More Eligibility: Patients with recurrent histologically proven malignant glioma (anaplastic astrocytoma or glioblastoma multiforme). Patients with anaplastic astrocytoma may have had up to ONE prior chemotherapy regimen in the adjuvant setting, but NO chemotherapy for recurrence. Patients with glioblastoma multiforme must be chemotherapy-naïve. Bidimensionally measurable enhancing lesions on CT or MRI.Objectives: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent malignant glioma. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.NCT Registration ID (from clinicaltrials.gov): NCT00036660NCI US Affiliation: YesClinical Trials Application (Canada): YesCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: January 10, 2002 Closing Date: December 17, 2002Permanently ClosedI162A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma Read More Eligibility: Patients with newly diagnosed (no prior chemotherapy permitted) or recurrent (only one prior adjuvant chemo regimen permitted), glioblastoma multiforme (GBM). Bidimensionally measurable disease. Stable dose of steroids. Paraffin embedded tumour sample available for study.Objectives: To assess the toxicity, pharmacokinetics, efficacy, MTD, and RPII dose(s) of RAD001C when given in combination with standard dose of Temozolomide in patients with GBM. Patients receiving enzyme inducing anti-epileptic drugs (EIAEDs) and those not receiving EIAEDs will be studied separately.NCT Registration ID (from clinicaltrials.gov): NCT00387400Participation: Participation in this study is restricted to invited centres.NCI US Affiliation: NoClinical Trials Application (Canada): YesCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: July 25, 2006 Closing Date: June 01, 2009Permanently ClosedI170A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma Read More Eligibility: Patients with recurrent glioblastoma multiforme (GBM) following primary surgery and radiation. No prior chemotherapy for recurrent disease permitted. Bidimensionally measureable disease. Stable dose of steriods. Paraffin embedded tumour sample available for study.Objectives: To determine the toxicity, MAD, and RPII dose of GW572016 when given in patients with GBM taking CYP3A4 enzyme inducing anti-epileptic drugs. To assess the efficacy of GW572016 when administered daily in appropriate recommended doses to patients with recurrent GBM.NCT Registration ID (from clinicaltrials.gov): NCT00099060Participation: Participation in this study is restricted to invited centres.NCI US Affiliation: YesClinical Trials Application (Canada): YesCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: December 16, 2004 Closing Date: May 08, 2007Permanently ClosedI204A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression. Read More Complexity Level: 2Eligibility: Patients must have histologically confirmed diagnosis of glioblastoma multiforme (GBM), with recurrent or progressive disease following or during primary treatment not curable with standard therapies. Must have formalin fixed paraffin embedded tissue available for translational studies. Presence of bidimensionally measurable enhancing lesions on CT or MRI, with at least one lesion with a minimum dimension of 1 cm x 1 cm (i.e. both dimensions must be > 1.0 cm). ECOG performance of 0, 1 or 2.Age > 18 years of age. Patients may have received prior adjuvant chemotherapy and/or concurrent chemoradiation as part of primary therapy, but must have received no therapy for recurrent/ progressive GBMObjectives: To determine the efficacy of PX-866 given orally daily in patients with glioblastoma at the time of first relapse or progression as assessed by objective response and early progression rates. To determine the safety and tolerability of PX-866 in patients with glioblastoma at first relapse/progression given in a daily oral schedule. To explore the relationship between objective response and molecular markers in archival tissue from glioblastoma patients treated with PX-866 orally daily. NCT Registration ID (from clinicaltrials.gov): NCT01259869Participation: Limited to invited centresNCI US Affiliation: NoClinical Trials Application (Canada): YesCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: December 09, 2010 Closing Date: September 24, 2012Permanently ClosedI27NCIC CTG Phase II Study of Trimetrexate in Glioma Read More NCT Registration ID (from clinicaltrials.gov): no NCTNCI US Affiliation: YesClinical Trials Application (Canada): NoCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: July 28, 1986 Closing Date: March 14, 1988Permanently ClosedI48NCIC CTG Phase II Study of "Intensive PCV-3" Chemotherapy For Anaplastic Oligodendroglioma Read More NCT Registration ID (from clinicaltrials.gov): no NCTNCI US Affiliation: NoClinical Trials Application (Canada): NoCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: February 06, 1989 Closing Date: September 02, 1992Permanently ClosedI54NCIC CTG Phase II Study of TCAR in Malignant Glioma Read More NCT Registration ID (from clinicaltrials.gov): no NCTNCI US Affiliation: YesClinical Trials Application (Canada): NoCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: April 18, 1990 Closing Date: May 28, 1991Permanently ClosedI75NCIC CTG Phase II Study of Topotecan in Patients With Malignant Glioma Read More NCT Registration ID (from clinicaltrials.gov): no NCTNCI US Affiliation: YesClinical Trials Application (Canada): NoCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: September 08, 1992 Closing Date: January 25, 1994Permanently ClosedI76NCIC CTG Phase II Study of Taxotere in Malignant Glioma Read More NCT Registration ID (from clinicaltrials.gov): no NCTNCI US Affiliation: NoClinical Trials Application (Canada): NoCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: April 04, 1994 Closing Date: April 28, 1995Permanently ClosedI94NCIC CTG Phase II Study of Gemcitabine in Patients With Malignant Glioma Read More NCT Registration ID (from clinicaltrials.gov): no NCTNCI US Affiliation: NoClinical Trials Application (Canada): NoCoordination: NCIC CTG Led TrialStatus: Permanently ClosedActivation Date: May 06, 1996 Closing Date: April 28, 1997Permanently Closed