4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases

Official Title

A Pragmatic Randomised, Multicentre Trial Comparing 4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases From Either Castration-resistant Prostate Cancer or Breast Cancer - The REaCT-BTA Study

Summary:

The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs. 4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process as the study is comparing standard schedules and not a new administration schedule.

Trial Description

Primary Outcome:

  • Health related quality of life scores measured with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Functional Domain (Physical Subdomain)
Secondary Outcome:
  • Pain will be measured through the EORTC-QLQ-BM22 (pain domain)
  • Health related quality of life scores
  • Time to development of symptomatic skeletal events (SSEs)
  • Total number of and time to subsequent on study SSE - to calculate Skeletal Morbidity Rates
  • For sites where Edmonton Symptom Assessment Scores (ESAS) are performed as standard of care, the ESAS scores will also be collected.
  • Adverse events/ toxicity profiles will be compared between the two different approaches.
  • An economic analysis on Health Services Issues
Bone metastases are common in patients with advanced breast and prostate cancers. Skeletal metastases can be associated with reduced Quality of Life (QoL), pain and skeletal-related events (SREs) (defined as pathological fractures, surgery/radiotherapy to bone, spinal cord compression and hypercalcaemia). Maintaining QoL while avoiding or delaying SREs are the main goals of therapy. Patients therefore receive bone-targeted agents (e.g. pamidronate, zoledronate and denosumab) which are typically given every 4 weeks. However, this 4 week dosing is based on convenience so the treatment could be given concurrently with chemotherapy. The half-life of these drugs in the bone is many months or even years. Hence studies have been performed evaluating 12-weekly therapy. These have confirmed similar palliative outcomes in the 4 vs 12-weekly groups for both breast and prostate cancer patients. However, there remains clinical equipoise about which dosing interval physicians prescribe. The current trial will compare these two schedules of bone-targeting agents (12- vs. 4-weekly) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process as the study is comparing standard schedules and not a new administration schedule.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society