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Phase 3
21 Years
80 Years
Not Enrolling
All Type of Cancers With Bony Metastasis

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Trial Information

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.

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Complete response rate

Outcome Description:

Complete response rate defined with Brief Pain Inventory score of zero plus no concomitant increase analgesic intake within 3 months after radiotherapy.

Outcome Time Frame:

24 weeks

Safety Issue:



Taiwan: Department of Health

Study ID:




Start Date:

July 2013

Completion Date:

June 2015

Related Keywords:

  • All Type of Cancers With Bony Metastasis
  • External-beam radiotherapy
  • Hyperthermia
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases