Trial Summary
What is the purpose of this trial?Bone is a common site of metastasis for a range of malignancies. Bone metastases have the potential to cause significant morbidity including pain, impairment of ambulation and reduced functional independence. Previous research has shown that pathological fractures are observed in 9 to 29 percent of patients with long bone metastases, and a high proportion of these require surgical intervention to relieve pain and restore function.
The goal of this study is to describe the clinical outcomes of patients with femoral metastases at high risk of pathological fracture. Patients referred for treatment of femoral metastases at high risk of fracture will be followed prospectively after undergoing with surgery (± post-operative radiotherapy), or radiotherapy alone. Patient and disease characteristics, ambulatory status and limb function will be documented before treatment. These Clinical outcomes of participants in each treatment group will be measured 6 weeks after treatment, and 3- and 6 months after enrolment, with particular reference to patient-reported outcomes relating to pain, ambulatory status, limb function and quality of life.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Surgery Alone vs Surgery + Radiation for Bone Cancer is an effective treatment?
The available research shows that combining surgery with radiation and zoledronic acid, a drug used to strengthen bones, can be effective for treating bone cancer. One study found that using zoledronic acid with radiotherapy helped manage bone cancer that had spread, reducing the risk of fractures and improving patient outcomes. Another study indicated that this combination could be beneficial for patients with bone metastases from lung cancer, as it reduced fracture risk and potentially improved survival. These findings suggest that adding radiation and zoledronic acid to surgery might offer better results than surgery alone for bone cancer.
12345What safety data exists for surgery and radiation treatment for bone cancer?
The research primarily discusses the safety and efficacy of zoledronic acid (ZA) in combination with chemotherapy for bone metastases, not specifically for surgery and radiation treatment for bone cancer. ZA is shown to be safe and effective in reducing skeletal-related events in various cancers, including osteosarcoma and genitourinary cancers. It is well tolerated with long-term use and has been used in combination with chemotherapy in metastatic osteosarcoma. However, specific safety data for the combination of surgery and radiation in bone cancer is not directly addressed in the provided studies.
36789Is Surgery Alone (also known as the drug Zometa) a promising treatment for bone cancer?
The research suggests that Zometa, a drug used in combination with other treatments, can help manage bone cancer by reducing complications like fractures and improving survival in patients with bone metastases. However, the studies focus on its use with other therapies, not as a standalone treatment.
25101112Eligibility Criteria
This trial is for adults with a confirmed cancer diagnosis, who have bone metastases in the femur at high risk of breaking (Mirels' score ≥8). Participants must be able to give consent and commit to follow-up. It's not suitable for individuals with lymphoma or those unable to participate.Inclusion Criteria
Histologically confirmed diagnosis of malignancy other than lymphoma
Presence of femoral metastases at high risk of pathologic fracture (Mirels' score 8 or more)
At least 18 years of age
+2 more
Participant Groups
The study compares two approaches for treating patients with high-risk femoral bone metastases: one group will receive surgery followed by radiation therapy, while another group will undergo surgery alone. The focus is on pain relief, mobility, limb function, and life quality after treatment.
2Treatment groups
Active Control
Group I: Surgery + Radiation TherapyActive Control1 Intervention
Group II: Surgery AloneActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Health Network, Princess Margaret HospitalToronto, Canada
Mount Sinai HospitalToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
[Clinical analysis of therapeutic effect of zoledronic acid combined with radiotherapy for metastatic bone cancer]. [2018]To evaluate the efficacy of zoledronic acid combined with local radiotherapy for limited metastatic bone cancer.
Retrospective evaluation of the clinical benefit of long-term continuous use of zoledronic acid in patients with lung cancer and bone metastases. [2019]For patients with bone metastases, skeletal-related events including fracture are common, can cause considerable morbidity, and may reduce overall survival (OS). This retrospective analysis assessed the effect of Zometa (zoledronic acid, ZOL), an intravenous bisphosphonate (IV-BP), on fracture risk and OS in patients with bone metastases from lung cancer (LC). (Zometa is a registered trademark of Novartis Pharmaceuticals Corporation, USA.)
Feasibility and dose discovery analysis of zoledronic acid with concurrent chemotherapy in the treatment of newly diagnosed metastatic osteosarcoma: a report from the Children's Oncology Group. [2021]Patients with metastatic osteosarcoma (OS) have a poor outcome with conventional therapies. Zoledronic acid (ZA) is a third-generation bisphosphonate that reduces skeletal-related events in many adult cancers, and pre-clinical data suggest a possible benefit in OS. This study assessed the maximum tolerated dose (MTD) and the feasibility of ZA when combined with chemotherapy in patients with metastatic OS.
Radiotherapy, Bisphosphonates and Surgical Stabilization of Complete or Impending Pathologic Fractures in Patients with Metastatic Bone Disease. [2022]To report the treatment outcomes of patients with metastatic bone disease with complete or impending pathologic fractures, who were treated with postoperative radiotherapy (RT), bisphosphonates or both after orthopedic stabilization.
A phase II study of palliative radiotherapy combined with zoledronic acid hydrate for metastatic bone tumour from renal cell carcinoma. [2021]Palliative radiotherapy is the standard of care for bone metastases. However, skeletal-related events, defined as a pathologic fracture, paraplegia, surgery or radiotherapy for local recurrence, or severe pain in previously irradiated bone with radio-resistant histology type still present high incidence. The primary objective of this study was to determine whether zoledronic acid hydrate and palliative radiotherapy could prevent local skeletal-related events.
Zoledronic acid in metastatic osteosarcoma: encouraging progression free survival in four consecutive patients. [2022]Zoledronic acid (ZA) is a third-generation bisphosphonate in widespread clinical use to reduce pain and skeletal events in patients from a variety of malignancies with bone metastases. Pre-clinical studies indicate that ZA inhibits osteosarcoma through direct anti-proliferative effects, immune activation and anti-angiogenic activity.
Zoledronic acid is effective in preventing and delaying skeletal events in patients with bone metastases secondary to genitourinary cancers. [2018]Patients with metastatic bone disease often have severe bone pain and debilitating skeletal complications. Zoledronic acid is the only bisphosphonate shown to be safe and effective in reducing skeletal-related events (SREs), including pathological fractures, spinal cord compression, and radiation or surgery to bone in patients with bone metastases from advanced prostate cancer or renal cell carcinoma (RCC). In both tumour types, zoledronic acid significantly decreased the overall risk of developing an SRE, delayed their onset and significantly reduced the incidence of SREs compared with placebo. In patients with RCC, zoledronic acid also significantly delayed the time to progression of bone lesions by 5 months compared with placebo. Zoledronic acid is safe and well tolerated with long-term use.
Efficacy and safety of denosumab versus zoledronic acid in patients with bone metastases: a systematic review and meta-analysis. [2018]Zoledronic acid (ZA) has been used as the standard treatment for patients with solid cancer or myeloma that has metastasized into bone. A new potential therapeutic strategy, denosumab, is being investigated in a variety of tumors. We conducted a systematic review with meta-analysis of randomized clinical trials assessing the efficacy and safety of denosumab in comparison with ZA in patients with bone metastases secondary to malignancy.
Under usage of zoledronic acid in non-small cell lung cancer patients with metastatic bone disease--a short communication. [2018]The use of zoledronic acid (ZA) is now recommended for patients with NSCLC and metastatic bone disease (MBD). We thus examined the rates of ZA administration in NSCLC looking specifically at the use of this drug with systemic chemotherapy (ZCt) and comparing overall survival between patients who had ZCt from diagnosis to those who had chemotherapy (Ct) alone.
Zoledronic acid and radiation: toxicity, synergy or radiosensitization? [2021]Zoledronic acid (Z) is a bisphosphonate used in hypercalcaemia-related cancer, in complications for bone metastasis and in postmenopausal osteoporosis and it has been related to osteoradionecrosis, especially when associated with radiation to the head and neck structures.
Assessment of zoledronic acid treatment patterns and clinical outcomes in patients with bone metastases from genitourinary cancers. [2019]Patients with bone metastases secondary to genitourinary (GU) cancer are at risk for skeletal-related events (SREs), including bone pain requiring palliative radiotherapy, fractures or surgery to bone, spinal cord compression, and hypercalcemia of malignancy. These SREs can be debilitating and potentially life-limiting. This study examined treatment practices and the association of treatment patterns with Zometa (zoledronic acid, ZOL), an intravenous bisphosphonate (IV-BP), with SREs and fractures. (Zometa is a registered trademark of Novartis Pharmaceuticals Corporation, USA.)
Successful percutaneous treatment of bone tumors using microwave ablation in combination with Zoledronic acid infused PMMA cementoplasty. [2020]Whilst surgical resection is traditionally used for the successful eradication of locally aggressive osseous tumors, it is often hazardous or unachievable, particularly in complex anatomic sites, such as the pelvis and spine. The authors present the use of microwave ablation in combination with Zoledronic acid (ZA) administration, alone and with the use of ZA-loaded polymethyl methacrylate (PMMA) to percutaneously treat unresectable bone tumors in 4 patients with giant cell tumors (GCT), multiple myeloma (MM) and breast cancer metastasis.