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 : Recruiting
First Posted : April 29, 2013
Last Update Posted : October 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|All Type of Cancers With Bony Metastasis||Other: Hyperthermia Radiation: External-beam radiotherapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: External-beam radiotherapy combine hyperthermia
Hyperthermia 42℃ ± 0.5℃ for 40min, 2 times/week within 2hr after irradiation. Radiation protocol are 3Gy 5 times a week for a total of 30Gy/10fx/2 weeks
Radiation: External-beam radiotherapy
Active Comparator: External-beam radiotherapy alone
External-beam radiotherapy alone comprising 30Gy/10 fractions, 5 times a week, administered with 2 weeks.
Radiation: External-beam radiotherapy
- 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.
- Adverse events [ Time Frame: 24 weeks ]Incidence of treatment-related adverse events from hyperthermia and RT.
- Tumor response [ Time Frame: 12 weeks ]To determine the difference of radiological tumor response in measurable indicated lesions on week 12.
- Pain relief [ Time Frame: 24 weeks ]To determine the difference in response of pain relief by Brief Pain Inventory score. To determine time and duration to pain relief on indicated lesion.
- Quality-of-life [ Time Frame: 24 weeks ]To compare the impact on quality-of-life using EORTC-C30 questionares.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842048
|Contact: Kwan-Hwa Chi, M.D.||886-2-28332211 ext 2273||M006565@ms.skh.org.tw|
|Contact: Yu-Shan Wang, Ph.D||886-2-28332211 ext 2614||T006659@ms.skh.org.tw|
|Shin Kong Wu Ho-Su Memorial Hospital||Recruiting|
|Taipei, Taiwan, 11101|
|Contact: Su-Chen Huang, M.S. 886-2-28332211 ext 2612 A007267@ms.skh.org.tw|
|Principal Investigator: Kwan-Hwa Chi Chi, M.D.|