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4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases (REaCT-BTA)

This study is currently recruiting participants.
Verified September 2016 by Ottawa Hospital Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02721433
First Posted: March 29, 2016
Last Update Posted: September 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  Purpose
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.

Condition Intervention Phase
Breast Cancer Prostate Cancer Metastasis Drug: Pamidronate Drug: Denosumab Drug: Zoledronate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Health related quality of life scores measured with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Functional Domain (Physical Subdomain) [ Time Frame: 1 year ]
    Units on a scale


Secondary Outcome Measures:
  • Pain will be measured through the EORTC-QLQ-BM22 (pain domain) [ Time Frame: 1 year ]
    Units on a scale

  • Health related quality of life scores [ Time Frame: 1 year ]
    Units on a scale

  • Time to development of symptomatic skeletal events (SSEs) [ Time Frame: 1 year ]
    SSEs defined from the date of randomization until the first date a patient experiences an SSE (an on-study SSE is defined as: use of radiotherapy to relieve skeletal symptoms, new symptomatic pathological bone fractures (vertebral or non-vertebral), spinal cord compression, tumour related orthopedic surgical intervention, hypercalcaemia). Any patient who does not experience a SSE will be censored on the last date the patient can be confirmed as SSE-free. Multiple measurements will be aggregated to arrive at one reported value.

  • Total number of and time to subsequent on study SSE - to calculate Skeletal Morbidity Rates [ Time Frame: 1 year ]
    Multiple measurements will be aggregated to arrive at one reported value.

  • For sites where Edmonton Symptom Assessment Scores (ESAS) are performed as standard of care, the ESAS scores will also be collected. [ Time Frame: 1 year ]
    Units on a scale

  • Adverse events/ toxicity profiles will be compared between the two different approaches. [ Time Frame: 1 year ]
  • An economic analysis on Health Services Issues [ Time Frame: 1 year ]
    We will perform a cost utility analysis alongside this pragmatic randomized controlled trial. The cost effectiveness of 4-week compared to 12-week BTA will be assessed in terms of the incremental cost per quality adjusted life year (QALY) gained from the perspective of health care system. Resource use and health utility will be measured from the trial at the follow up interviews. Health utility values would be estimated from the study questionnaires.


Estimated Enrollment: 250
Study Start Date: August 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 4 weekly bone-targeted agent x 1 year
Bone targeting agents as standard of care
Drug: Pamidronate
Bone-targeted agent as standard of care
Other Name: Aredia
Drug: Denosumab
Bone-targeted agent as standard of care
Other Name: Prolia
Drug: Zoledronate
Bone-targeted agent as standard of care
Other Name: Zometa
Active Comparator: 12 weekly bone-targeted agent x 1 year
Bone targeting agents as standard of care
Drug: Pamidronate
Bone-targeted agent as standard of care
Other Name: Aredia
Drug: Denosumab
Bone-targeted agent as standard of care
Other Name: Prolia
Drug: Zoledronate
Bone-targeted agent as standard of care
Other Name: Zometa

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer (36) or breast cancer.
  • About to start or currently receiving BTA therapy.
  • ECOG performance status ≤ 2 and life expectancy of more than 12 months.
  • Serum creatinine >30 ml/min and corrected serum calcium ≥ 2 mmol/l
  • Age ≥ 18 years.
  • Able to provide verbal consent

Exclusion Criteria:

  • For CRPC patients - Definite contraindication for denosumab at baseline (e.g. hypocalcaemia [Albumin-corrected serum calcium < 2.0 mmol/l]).
  • History of or current evidence of osteonecrosis of the jaw.
  • Radiotherapy or surgery to the bone planned within 4 weeks after randomization.
  • Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug (e.g. fructose).
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721433


Contacts
Contact: Mark Clemons, MD mclemons@toh.on.ca

Locations
Canada, Ontario
The Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada
Principal Investigator: Mark Clemons, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Mark Clemons, MD The Ottawa Hospital
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02721433     History of Changes
Other Study ID Numbers: 16-01
First Submitted: March 10, 2016
First Posted: March 29, 2016
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic acid
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs