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Concurrent Xeloda and Radiotherapy for Bone Metastases

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ClinicalTrials.gov Identifier: NCT00192777
Recruitment Status : Unknown
Verified September 2005 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : September 19, 2005
Last Update Posted : October 8, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:

Hypothesis: Radiosensitization using Xeloda should improve the rate of complete pain relief.

Primary Objective:

  • To determine the frequency of pain relief for the proposed regimen.

Secondary Objective(s):

  • To determine the duration of pain relief and narcotic relief for the proposed regimen.
  • To determine the frequency of narcotic relief for the proposed regimen.
  • To determine the toxicity of concurrent UFT and radiotherapy in patients with bone metastases.

Condition or disease Intervention/treatment Phase
Solid Tumors Bone Metastases Drug: Xeloda Procedure: External Beam Radiotherapy Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concurrent Xeloda and Radiotherapy for Bone Metastases
Study Start Date : November 2004
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The frequency of pain relief for the proposed regimen, using a scale that takes into account the subjective feeling and the use of analgesics [ Time Frame: after 3 months ]

Secondary Outcome Measures :
  1. The duration of pain relief and narcotic relief for the proposed regimen after one year
  2. The frequency of narcotic relief for the proposed regimen after one year
  3. The toxicity of concurrent UFT and radiotherapy in patients with bone metastases after one year

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must be 18 years of age or older.
  2. The patient must have epithelial malignancy.
  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 must have an estimated life expectancy of 3 months or greater.
  6. Signed study-specific informed consent.
  7. Karnofsky performance status  40.
  8. Calculated creatinine clearance > 50 ml/min
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00192777


Contacts
Contact: Zvi Bernstein, MD 972 4 8541812 z_bernstein@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Zvi Bernstein, MD    972 4 8541812    z_bernstein@rambam.health.gov.il   
Sub-Investigator: Zvi Bernstein, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Kuten Abraham, Prof. Dept. of Oncology, Rambam Health Care Campus
More Information

ClinicalTrials.gov Identifier: NCT00192777     History of Changes
Other Study ID Numbers: BM-RT-Xeloda.CTIL
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: October 8, 2007
Last Verified: September 2005

Keywords provided by Rambam Health Care Campus:
Solid Tumors
Bone Metastases
Radiotherapy
Xeloda
Concurrent
Radiosensitization

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents