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Chemoradiation for Bone Metastasis

This study has been completed.
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01784393
First received: January 14, 2013
Last updated: February 3, 2013
Last verified: April 2007
  Purpose

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 Intervention Phase
Breast Cancer
Bone Metastasis
Pain
Radiation: chemoradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chemoradiation With Capecitabine for Palliation of Pain From Bone Metastasis

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 29
Study Start Date: May 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784393

Locations
Israel
Rabin Medical Center, Beilinson Campus
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Sheba Medical Center
Investigators
Principal Investigator: Yulia Kundel, MD Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01784393     History of Changes
Other Study ID Numbers: Bone-X-11
Study First Received: January 14, 2013
Last Updated: February 3, 2013
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Bone Marrow Diseases
Bone Neoplasms
Breast Neoplasms
Neoplasm Metastasis
Bone Diseases
Breast Diseases
Hematologic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on November 23, 2014