Bone Metastases Clinical Trial
— EXPLOREOfficial title:
A Phase III Multicenter Randomized Trial Assessing the Efficacy of Post-Operative Conventional External Beam Radiation Therapy Following Orthopaedic Surgery in Patients With Lower Extremity Bone Metastases
NCT number | NCT04109937 |
Other study ID # | EXPLORE |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2020 |
Est. completion date | October 2026 |
Verified date | May 2023 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2026 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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? |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subsequent surgery after primary surgery | Requirement of a subsequent surgery | 12 months following the date of primary surgery | |
Secondary | Re-irradiation/radiation | Requirement for re-irradiation in arm 2 or radiation in arm 1 | Weeks 2 & 6, Months 3, 6, 12, 18, and 24 | |
Secondary | Subsequent surgery (between 13 months and 24 months) | Requirement of subsequent surgery past 12 months (between 13 months and 24 months) | Between 13 months and 24 months following date of primary surgery | |
Secondary | Post-operative functional status and Karnofsky Performance Status (KPS) | The best, median, and worst post-operative functional status and KPS will be derived for each patient, and the Wilcoxin rank sum test will be used to compare the difference between treatment arms | Weeks 2 & 6, Months 3, 6, 12, 18, and 24 | |
Secondary | Post-operative pain and analgesic use | The lowest, median, and worst post-operative pain score will be derived for each patient, and the Wilcoxin rank sum test will be used to compare the difference between treatment arms. The cumulative and mean of analgesic use will presented by treatment arm. | Weeks 2 & 6, Months 3, 6, 12, 18, and 24 | |
Secondary | Radiologically determined local progression | Time to radiological local disease progression is defined as the time from randomization to the date of documented radiological logical disease progression or death whichever comes first. | Months 3, 6, 12, 18, and 24 | |
Secondary | Quality of life through functional ability | Quality of life measured measured using EORTC quality of life questionnaire (QLQ)-C15-Pal and EORTC quality of life questionnaire (QLQ)-BM22. This questionnaire includes for multi-item scales and six individual items. All items were scaled from 1 (not at all) to 4 (very much) in which a higher score indicates greater distress in symptom scales while a higher score in functional scale indicates greater functional ability. The EORTC QLQ-BM22 is a 22-item module that addresses disease symptoms related to bone metastasis. It has four subscales (painful sites, pain characteristics, functional interference and psychosocial aspects). All items were scaled from 1 (not at all) to 4 (very much), in which a higher score indicates greater distress in symptom scales while a higher score in functional scale indicates greater functional ability | Day of randomization, weeks 2 and 6, months 3, 6, 12, 18, and 24 | |
Secondary | Overall survival | Overall survival is defined as the time from randomization to the date of death from any cause, or censored at their last known alive data before or on data cutoff date | Weeks 2 & 6, Months 3, 6, 12, 18, and 24 | |
Secondary | Cost-effectiveness | Determination of the incremental cost-effectiveness by prospectively collecting economic and resource utilization information. The objective is to determine an incremental cost effectiveness ratio reported as a cost per subsequent surgery avoided for both treatment arms. The mean overall cost per patient for each of the two study treatment arms will be calculated to determine the addition cost per surgery avoided. | Weeks 2 & 6, Months 3, 6, 12, 18, and 24 |
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