Status:
UNKNOWN
Comparing the Effectiveness of Combined Hyperthermia and External Beam Radiation (EBRT) Versus EBRT Alone in Treating Patients With Painful Bone Metastases
Lead Sponsor:
Shin Kong Wu Ho-Su Memorial Hospital
Conditions:
All Type of Cancers With Bony Metastasis
Eligibility:
All Genders
21-80 years
Phase:
PHASE3
Brief Summary
The main goals of deep hyperthermia combined with external beam radiation (EBRT) on bone metastases are the response on pain relief, duration of response and time to achieve complete pain relief.
Detailed Description
The goal of this study is to conduct comparative data on the efficacy of low temperature (40-43℃ range) deep hyperthermia adding on external beam radiation for treatment of metastatic bone tumors. The...
Eligibility Criteria
Inclusion
- Histologically or clinically confirmed solid tumor metastasis with index lesion involving or abutting bone. \*Index lesion means an irradiated field covered lesions contoured from CT-Simulation which may generally less than 20cm, include 4-5 vertebra bodies, sacrum plus adjacent iliac lesions or a segment of femerol bone. Each patient can only have one index lesion for this study.
- Index lesion with bone destruction either osteolytic or osteoblastic in nature as assessed on CT or MRI imaging
- If the nature of the metastatic disease has been previously documented, the index lesion to be treated does not require further documentation (i.e., biopsy)
- ≥ One primary painful metastatic site. The most painful site that need treatment first will be elected as index lesion site for evaluation of response. Additional less painful metastatic sites may be present. Patients who elect to have another course of RT treatment on different metastatic sites after the initial treatment are allowed.
- Worst pain in the last 24 hours must be ≥ 4 on a 0-10 numeric scale.
- Index lesion causing clinical or radiographic evidence of partial spinal cord or cauda equina compression/effacement is allowed.
- Have developed pain or have persistent pain while on a stable chemotherapy, hormonal therapy, target therapy or bisphosphonate therapy regimen is allowed. There will be no change of chemotherapy, hormonal therapy, or bisphosphonate therapy for 4 weeks before and after radiotherapy
- ECOG performance status 0-3
- Life expectancy ≥ 3 months
- Patients with impending fracture of weight bearing bone or patients with symptoms of spinal cord compression should have surgical opinion before the start of radiotherapy. Patient should not be able to be enrolled in this study if surgery is scheduled.
Exclusion
- Index lesion involves the skull
- Index lesion has evidence of a pathologic fracture, impending fracture need immediate surgery are not eligible. Those patients had received decompression surgery are not eligible.
- Has undergone prior radiotherapy at the index lesion
- Those who chemotherapy or systemic treatment will be changed during study period.
- Patients had history of metal implant inside or outside irradiation field are not eligible .
- Patients had history of pacemaker insertion due to arrhythmia are not eligible.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01842048
Start Date
July 1 2013
End Date
June 1 2019
Last Update
October 13 2016
Active Locations (1)
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1
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 11101