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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04549207
Other study ID # REaCT-Hold BMA
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 9, 2020
Est. completion date November 2025

Study information

Verified date May 2023
Source Ottawa Hospital Research Institute
Contact Lisa Vandermeer
Phone 613-737-7700
Email lvandermeer@toh.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators propose is to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date November 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer or breast cancer who are currently receiving BMA - Patient has received BMA for 2 or more years counting from the first BMA dose for bone metastases - Age 18 years or older - Able to provide verbal consent Exclusion Criteria: - Definite contraindication for BMA - History of, or current evidence of osteonecrosis of the jaw - Radiotherapy or surgery to the bone planned within 4 weeks after randomization - Current hypercalcemia defined as corrected serum calcium of > 3 mmol/L (from standard bloodwork completed within one month prior to treatment dose)

Study Design


Intervention

Drug:
Bone modifying agent
Use of bone modifying agent

Locations

Country Name City State
Canada The Ottawa Hospital Cancer Centre Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Frequency of subsequent de-escalation or discontinuation of BMAs In the continuation arm, frequency of subsequent de-escalation or discontinuation of BMAs 2 years post-randomization
Other Frequency of restarting standard dosing BMA In the de-escalation arm, frequency of restarting standard dosing BMA (and the reasons for restarting) 2 years post-randomization
Other Overall survival Overall survival during study duration 2 years post-randomization
Primary Health related quality of life scores Health related quality of life (HR-QoL) scores measured by the European Organisation for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-C30 physical functioning subscale and the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire (QLQ)- for patients with bone metastasis (BM)22 functional interference subscale. The EORTC-QLQ-C30 is an internationally accepted and validated tool in multiple large study cohorts capturing HR-QoL from a multi-dimensional and global perspective in oncology. EORTC-QLQ-BM22 has been validated for use specifically in bone metastases. They were developed in collaboration with patients, healthcare professionals and thorough review of the literature, and therefore important to all stakeholders; the scales are well-defined and easily measured, and HR-QoL is a relevant goal of care in the palliative care setting. 48 weeks after randomization (one year of treatment)
Secondary Symptomatic Skeletal Event (SSE) Number of patients with one or more SSEs (defined as: use of radiotherapy to relieve skeletal symtoms, new symptomatic pathological bone fractures [vertebral or non-vertebral], spinal cord compression, tumour-related orthopedic surgical intervention, or hypercalcaemia] during trial period) up to 2 years post-randomization. 2 years post-randomization
Secondary Time to development of Symptomatic Skeletal Event Defined from the date of randomization until the first date of patient experience an SSE. Any patient who does not experience an SSE will be censored on the last follow-up date and the patient can be confirmed as SSE-free (up to 2 years). 2 years post-randomization
Secondary Symptomatic Skeletal Event-free survival SSE-free survival (composite of time to first SSE and time to death) 2 years post-randomization
Secondary Skeletal morbidity Skeletal morbidity rate defined as ration of number of SSEs for each subject divided by the subject's time at risk in years. 2 years post-randomization
Secondary Quality of life of cancer patients using the EORTC-QLQ-C30 Assess quality of life of cancer patients using the EORTC-QLQ-C30 (cancer patient specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment") 48 weeks post-randomization
Secondary Quality of life of cancer patients using the EORTC-QLQ-BM22 Assess quality of life of cancer patients using the EORTC-QLQ-BM22 (patients with bone metastases specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment") 48 weeks post-randomization
Secondary BMA-related toxicity rates BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments 2 years post-randomization
Secondary Incremental cost-effectiveness rations Defined as the difference in cost between two possible interventions, divided by the difference in their Quality Adjusted Life Year (QALY) gained. 2 years post-randomization
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