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Chemoradiation for Bone Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784393
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : February 5, 2013
Sheba Medical Center
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:

Pain from bone metastases of breast cancer origin is treated with localized radiation. Modulating doses and schedules has shown little efficacy in improving results. Given the synergistic therapeutic effect reported for combined systemic chemotherapy with local radiation in anal, rectal, and head and neck malignancies, the investigators sought to evaluate the tolerability and efficacy of combined capecitabine and radiation for palliation of pain due to bone metastases from breast cancer Hypothesis: Given the hypothesis that regimens employing greater intensity radiation yield higher rates of pain relief, radiosensitization using a tumor targeted drug like Xeloda should improve the rate of complete pain relief as compared to radiosensitization with 5FU alone.

Primary Objective:

To determine the frequency and duration of pain relief and narcotic relief for the proposed regimen.

Secondary Objective:

To determine the toxicity of concurrent Capecitabine and radiotherapy in breast cancer patients with bone metastases.

Condition or disease Intervention/treatment Phase
Breast Cancer Bone Metastasis Pain Radiation: chemoradiation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemoradiation With Capecitabine for Palliation of Pain From Bone Metastasis
Study Start Date : May 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from Baseline in pain score at 12 wks [ Time Frame: 12 weeks ]
    Patients were asked to score their pain on a scale of 0 (no pain) to 10 (worst possible pain) before treatment and at 1, 2, 4, 8 and 12 weeks after treatment initiation.

Secondary Outcome Measures :
  1. Change in pain medications consupmtion at 12 weeks compared to basline [ Time Frame: 12 weeks ]
    Consumption of analgesics was evaluated by the physician using the 5-point WHO score, as follows: level 0, no analgesics required; level 1, non-narcotic analgesics required occasionally; level 2, non-narcotic analgesics required regularly; level 3, narcotic analgesics required occasionally; level 4, narcotic analgesics required regularly

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient must be 18 years of age or older
  2. The patient must have histologically proven breast adenocarcinoma
  3. Radiographic evidence of bone metastasis is required .Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging
  4. The patient must have pain that appears to be related to the radiographically documented metastasis
  5. Patients receiving systemic therapy with Capecitabine to metastatic disease (according to health basket)
  6. Patients must have an estimated life expectancy of 3 months or greater
  7. Patients will be eligible for treatment of multiple metastases only if these can be included in no more than two treatment sites
  8. Signed study specific informed consent
  9. Karnofsky Performance Status > 40
  10. Calculated Creatinine Clearance > 50 ml/min
  11. ALT and AST no greater than 3 5 times the institutional normal; bilirubin and serum creatinine no greater than 1.5 times normal; ANC greater than 1500, and platelets at least 100,00

Exclusion Criteria:

  1. Prior radiation therapy or prior palliative surgery to the painful site
  2. Impending fracture of the treatment site or planned surgical fixation of the bone
  3. Patients with clinical or radiographic evidence of spinal cord or cauda equina compression
  4. Patients receiving systemic radionuclides (strontium, samarium, etc.) within 60 days prior to registration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01784393

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Rabin Medical Center, Beilinson Campus
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Sheba Medical Center
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Principal Investigator: Yulia Kundel, MD Rabin Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Rabin Medical Center Identifier: NCT01784393    
Other Study ID Numbers: Bone-X-11
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: April 2007
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases