Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-28 @ 4:10 PM
Study NCT ID:
NCT01428895
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2011-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral Bone Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2011-05-19', 'studyFirstSubmitQcDate': '2011-09-02', 'lastUpdatePostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status', 'timeFrame': '6 months', 'description': 'Patient will be assessed at baseline, 6 weeks, 3 months and 6 months'}], 'secondaryOutcomes': [{'measure': 'To describe patterns of management in patients with femoral metastases at high risk of pathological fracture - Perioperative Morbidity and Mortality for surgical patients; pain score and performance status; QOL', 'timeFrame': '6 months', 'description': 'Patients will be assessed at baseline, 6 weeks, 3 months and 6 months'}, {'measure': 'To describe patient and disease characteristics of major management groups (surgery ± radiotherapy, radiotherapy alone due to preference, radiotherapy alone due to co-morbid conditions) - Assessment of lower limb function', 'timeFrame': '6 months', 'description': 'Patient will be assessed at baseline, 6 weeks, 3 months, and 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bone Metastases', 'Femoral Metastases'], 'conditions': ['Cancer', 'Metastatic Malignant Neoplasm to Femur', 'Risk of Fracture']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed diagnosis of malignancy other than lymphoma\n* Presence of femoral metastases at high risk of pathologic fracture (Mirels' score 8 or more)\n* At least 18 years of age\n* Able to provide written informed consent\n* Able to participate in follow-up\n\nExclusion Criteria:\n\n* Surgical consultation for the purpose of obtaining a tissue/histological diagnosis only, not for treatment\n* Histological diagnosis of lymphoma"}, 'identificationModule': {'nctId': 'NCT01428895', 'briefTitle': 'Femoral Bone Metastases', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Prospective Cohort Study of the Role of Surgery and/or Radiotherapy for Bone Metastases of the Femur at High Risk of Pathological Fracture', 'orgStudyIdInfo': {'id': 'OCREB 09-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery Alone', 'interventionNames': ['Procedure: Surgery Alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery + Radiation Therapy', 'interventionNames': ['Other: Combined Surgery and Radiation therapy']}], 'interventions': [{'name': 'Surgery Alone', 'type': 'PROCEDURE', 'description': "Although we are looking at two groups, this intervention is not protocol specific but is part of the patient's standard management plan. The protocol specific part of the study is completely observational. This involves data being recorded by the attending physician during assessment and patient accounts recorded in the form of questionnaires.", 'armGroupLabels': ['Surgery Alone']}, {'name': 'Combined Surgery and Radiation therapy', 'type': 'OTHER', 'description': "Although we are looking at two groups, this intervention is not protocol specific but is part of the patient's standard management plan. The protocol specific part of the study is completely observational. This involves data being recorded by the attending physician during assessment and patient accounts recorded in the form of questionnaires.", 'armGroupLabels': ['Surgery + Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Peter Ferguson, MD', 'role': 'CONTACT', 'email': 'PFerguson@mtsinai.on.ca', 'phone': '416 586-4800', 'phoneExt': '8687'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rebecca Wong, MB ChB', 'role': 'CONTACT', 'email': 'Rebecca.Wong@rmp.uhn.on.ca', 'phone': '416 946 4501', 'phoneExt': '2126'}], 'facility': 'University Health Network, Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Rebecca Wong, MB ChB', 'role': 'CONTACT', 'email': 'Rebecca.wong@rmp.uhn.on.ca', 'phone': '416 946 4501', 'phoneExt': '2126'}], 'overallOfficials': [{'name': 'Rebecca Wong, MB ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Princess Margaret Hospital'}, {'name': 'Peter Ferguson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Hospital, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}