WithdrawnNot Applicable

External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial

Stopped: Feasibility couldn't be worked out

Canada0Started 2020-10

Plain-language 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 receiving radiation therapy after Orthopaedic surgery to patients who will not receive radiation therapy post-surgery. The primary objective of the study is to compare the need for a subsequent surgery at the same treatment site within 12 months of the initial surgery. Additionally, the need for radiation or re-irradiation, functional status, performance status, pain scores, radiologically detected local disease progression, and overall length of survival will be compared at clinical endpoints for the two study arms. It is hypothesized that those randomized to receive post-operative radiation therapy will less likely need a subsequent surgery within the 12 months after the primary surgical intervention. This may optimize the quality of life for this patient population.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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?

What they're measuring

Subsequent surgery after primary surgery

Timeframe: 12 months following the date of primary surgery

Trial details

NCT IDNCT04109937

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10