Canadian Cancer Trials Group - Tumour Bank
Logged in as: Public
Location: Home - Disease Sites - - SC24

SC24 Details
Status: Closed 
Activation Date: 2015JUL28
Closing Date: 2019SEP27
Phase: II-III 

Description: A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) versus Conventional Palliative Radiotherapy (CRT) for Patients with Spinal Metastases  

Eligibility: Patients with tumours (excluding seminoma, small cell lung cancer and metastases from hematologic malignancies) who have MRI-documented spinal metastases, suitable for receiving radiation therapy, and fulfill the following criteria: (a) Pain secondary to spinal metastases requiring treatment; (b) <=3 consecutive spinal segments involved by tumour to be included in the target volume  

Objective: PRIMARY ENDPOINT: Phase II study: The ability to accrue 54 patients over an 18 month period to a study that randomizes patients with spinal metastases to Stereotactic Body Radiotherapy (SBRT) or Standard Conventional Radiotherapy (CRT) within a Canadian multicentre setting. Phase III study: To assess complete pain response in the treatment area at 3 months post-radiation. SECONDARY ENDPOINTS: (1) Complete pain response in the treatment area at 6 months post-radiation; (2) Radiation site progression-free survival (RSS PFS) at 3 and 6 months; (3) Spinal Instability Neoplastic Score at 3 and 6 months; (4) Overall Surivval; (5) Adverse event profile; (6) Healthe-related Quality of Life; (7) Economic Analysis; (8) Radiotherapy Quality Assurance (RTQA) compliance. TERTIARY ENDPOINTS: (1) Radiomics; (2) Biobanking for future correlative studies TERTIARY ENDPOINT: Biobanking for future correlative Studies. 

Participation: Open to member centres 

Lay Description: Spinal metastases may cause severe pain and lead to fractures of vertebrae or outgrowths of tumour that compress the spinal cord resulting in paralysis. These outcomes cause considerable suffering and disability. Spinal metastases are treated with low doses of radiation and narcotic medications. Stereotactic body radiation therapy (SBRT) is a new way of providing radiation with ultra-high precision. While there is a strong biologic basis suggesting that SBRT may improve the treatment of spinal metastases, evidence from large studies (200 patients or more) is needed. The first part of the randomized trial (phase II) looked at whether it was possible (feasible) to provide these treatments in cancer centres across Canada, by aiming to recruit 54 participants within 18 months. This part of the study was successfully completed in early 2017. The second component of this study, called a randomized phase III trial, is now underway. It involves recruiting 174 more participants. 

Primary Publication Show

Other Publications Show

Inventory
Hide Tissue Samples
Hide TMA Samples
Hide Fluid Samples

© 2024 Canadian Cancer Trials Group.