Comparing the Effectiveness of Combined Hyperthermia and External Beam Radiation (EBRT) Versus EBRT Alone in Treating Patients With Painful Bone Metastases
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ClinicalTrials.gov Identifier: NCT01842048 |
Recruitment Status : Unknown
Verified October 2016 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was: Recruiting
First Posted : April 29, 2013
Last Update Posted : October 13, 2016
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Tracking Information | |||
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First Submitted Date ICMJE | April 24, 2013 | ||
First Posted Date ICMJE | April 29, 2013 | ||
Last Update Posted Date | October 13, 2016 | ||
Study Start Date ICMJE | July 2013 | ||
Estimated Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Complete response rate [ Time Frame: 24 weeks ] Complete response rate defined with Brief Pain Inventory score of zero plus no concomitant increase analgesic intake within 3 months after radiotherapy.
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Comparing the Effectiveness of Combined Hyperthermia and External Beam Radiation (EBRT) Versus EBRT Alone in Treating Patients With Painful Bone Metastases | ||
Official Title ICMJE | Not Provided | ||
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. There are 3 reasons of conducting this clinical trial. Firstly, radiotherapy is most effective modality for bony metastases treatment, but only limited radiation dose can be delivered to metastatic bony metastatic sites with relatively short response duration observed clinically. Since it is a palliative treatment for pain relief, some patients develop recurrent pain at the same lesions a few months later. Most patients must accept their hopeless conditions and accept toward the end of their lives due to difficulty of reirradiation. There is urgently need for more effective treatment. Secondly, most combination of hyperthermia and radiation trials were relatively high dose of radiation, with the basic idea of hyperthermic radiosensitization, the combination of hyperthermia and radiotherapy on bone metastasis is warrant. Clinical trials experiences on relatively less deep tumors such as breast, head and neck cancers, extremity sarcoma or melanoma may not be applied on deep seated tumors. Bony metastases are usually deep seated lesions with hard cortex bone surrounded. The real benefit of hyperthermia can be highlighted on bony metastases. Thirdly, metastatic bony microenvironment are critical for the providing of bone marrow-derived immune suppressor cells circulating to systemic tumor microenvironment, mild thermal therapy to metastatic bony microenvironment may have dual immunomodulatory effects: direct enhancement of immune cell activity through thermally sensitive molecular pathways associated with immune cell function/activation, and, indirect enhancement of immunosurveillance through a reduction in hypoxia-induced immune suppressor cells around metastatic foci via improved tumor vascular perfusion. An unexpected survival benefit may demonstrated from this study. Patients are stratified according to solitary or multiple sites, primary cancer type (Breast or prostate vs others), and severity of pain (i.e., worst pain score in the last 24-hour period) (4-6 vs 7-10). Patients are randomized to 1 of 2 treatment arms. Treatment protocol A was designed to compare the response of matched tumors in the same patient treated by radiation alone or by radiation combined with hyperthermia when the patient had multiple tumors. Two tumors of comparable size were treated with either protocol A or B, and the responses were compared. The tumor size was computed as the product of maximum length times maximum width. |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | All Type of Cancers With Bony Metastasis | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
152 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date ICMJE | June 2019 | ||
Estimated Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 80 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Taiwan | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01842048 | ||
Other Study ID Numbers ICMJE | 20120305D | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Shin Kong Wu Ho-Su Memorial Hospital | ||
Study Sponsor ICMJE | Shin Kong Wu Ho-Su Memorial Hospital | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Shin Kong Wu Ho-Su Memorial Hospital | ||
Verification Date | October 2016 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |