Hypofractionated Radiotherapy (16/2) for the Palliation of Complicated Bone Metastases in Patients With KPS
NCT ID: NCT02376322
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2014-07-31
2016-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiotherapy in bone metastases
The purpose of this one armed, phase II trial is to determine the efficacy and safety profile of a hypofractionated radiotherapy regimen, 16 Gy in 2 fractions with an interval of one week, for the palliation of complicated bone metastases in patients with poor performance status.
Radiotherapy
Hypofractionated radiotherapy regimen, 16 Gy in 2 fractions in complicated bone metastases in patients with poor performance status
Interventions
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Radiotherapy
Hypofractionated radiotherapy regimen, 16 Gy in 2 fractions in complicated bone metastases in patients with poor performance status
Eligibility Criteria
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Inclusion Criteria
2. Patients aged 18 and above.
3. Advanced cancer patients with at least one complicated bone metastasis. A complicated bone metastasis will be operationally defined as a bone metastasis that has an accompanying: soft tissue mass or extraosseous component penetrating the normal cortical boundary; neuropathic pain; post surgical intervention for bone fixation; impending fracture or high fracture risk in weight bearing long bone as defined by Harrington's criteria but not surgical candidate: lytic bone lesion involving more than ½ the diameter of the bone cortex , greater than 2.5 cm in greatest diameter, or in the intertrochanteric line (29).
4. Patients with Karnofsky Performance Status (KPS) 30-60 at the time of baseline evaluation.
5. Patients who are planned to receive radiation treatment to the complicated site(s) being followed for study.
6. Patients who had surgery for complicated bone metastases.
7. Patients who are currently taking any systemic therapy (i.e. chemotherapy, hormone therapy, or bone modifying agents) or planning to begin systemic therapy within two weeks of treatment will be allowed to participate in the study; study personnel will note any use of systemic therapy in the study records.
8. Patients who are able to provide a worst pain score at the complicated site(s) being followed for study.
9. Patients who are able and willing to fill out a daily diary.
10. Patients who are able to provide informed consent prior to being enrolled to the study.
Exclusion Criteria
2. Patients who are surgical candidates with pathologic fractures or lesions at high risk for pathologic fracture in the humerus, radius, ulna, femur, tibia, or fibula. They will be eligible for post-operative hypofractionated radiotherapy.
3. Patients with spinal cord compression or cauda equina syndrome.
4. Patients who are currently receiving any radiopharmaceuticals.
5. Patients who are unable to record a pain score, complete a daily diary or to communicate requested information to study personnel.
18 Years
ALL
No
Sponsors
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Santa Casa de Porto Alegre
OTHER
Responsible Party
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Mauricio F Silva
Medical Doctor at Radiation Oncology Unity
Principal Investigators
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Maurício F Silva, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical Doctor at Radiation Oncology Unit
Locations
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ISCMPA
Porto Alegre, Rio Grande do Sul, Brazil
ICESP
São Paulo, São Paulo, Brazil
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
S. Maria Hospital
Terni, , Italy
Countries
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Other Identifiers
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ISCMPA01
Identifier Type: -
Identifier Source: org_study_id