Status:
WITHDRAWN
External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Bone Metastases
Lower Extremity Fracture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the present study is to evaluate the effectiveness of post-operative radiation therapy in lower extremity bone metastases. This trial will compare the health outcomes of patients rece...
Detailed Description
The incidence of bone metastases in advanced cancer patients is substantial, representing 70% of all metastatic sites. Approximately 5-10% of all patients with bone metastases develop pathological fra...
Eligibility Criteria
Inclusion
- Is the patient 18 years of age or older at the time of randomization?
- Does the patient have histologically or cytologically proven malignancy?
- Does the patient have imaging confirming presence of bone metastases corresponding to clinically painful area?
- Does the patient have established bone metastatic pathological fracture(s) lower extremity OR has impending pathological fracture(s)?
- Does patient have KPS ≥40 with estimated survival of ≥ 6 months?
- Was informed consent obtained?
Exclusion
- Did the patient have a prior impending or prior pathological fracture to the site and was previously fixed with orthopaedic surgery?
- Did the patient receive prior radiation to the site (external beam or stereotactic body radiation)?
- Did the patient have a radio-resistant tumor (renal cell carcinoma or melanoma)?
- Did the patient plan for radical resection of the bone metastases?
- Did the patient receive or is planning to receive other intra-operative tumor ablative therapies?
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04109937
Start Date
October 1 2020
End Date
October 1 2026
Last Update
May 6 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5