Brain Disease Site

Complexity Level: 2

Eligibility: 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, timing

Objectives: 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 centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: June 19, 2024

Chair: (Canada) Dr. Marshall W. Pitz, CancerCare Manitoba, (204) 787-8642

Complexity Level: 2

Eligibility: - 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 evaluation

NCT Registration ID (from clinicaltrials.gov): NCT03550391
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: May 25, 2018

Chair: (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) 713-3600

Complexity Level: 2

Eligibility: 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): NCT00887146
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 28, 2010 Closing Date: January 14, 2015

Complexity Level: 2

Eligibility: 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): NCT04114981
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: May 22, 2020 Closing Date: October 14, 2022

Chair: (Canada) Dr. Jeffrey Greenspoon, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495

Complexity Level: 2

Eligibility: 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 ULN

Objectives: 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): NCT00887146
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: March 22, 2016 Closing Date: June 10, 2024

Chair: (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, (403) 944-1260

Complexity Level: 2

Eligibility: Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis

Objectives: 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): NCT00626990
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 22, 2009 Closing Date: September 15, 2015

Chair: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277