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Concurrent Xeloda and Radiotherapy for Bone Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00192777
First received: September 13, 2005
Last updated: October 5, 2007
Last verified: September 2005
History of Changes

September 13, 2005
October 5, 2007
November 2004
Not Provided
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 ]
The frequency of pain relief for the proposed regimen after 3 months, using a scale that takes into account the subjective feeling and the use of analgestics.
Complete list of historical versions of study NCT00192777 on ClinicalTrials.gov Archive Site
  • The duration of pain relief and narcotic relief for the proposed regimen after one year
  • The frequency of narcotic relief for the proposed regimen after one year
  • The toxicity of concurrent UFT and radiotherapy in patients with bone metastases after one year
  • The duration of pain relief and narcotic relief for the proposed regimen after one year.
  • The frequency of narcotic relief for the proposed regimen after one year.
  • The toxicity of concurrent UFT and radiotherapy in patients with bone metastases after one year.
Not Provided
Not Provided
 
Concurrent Xeloda and Radiotherapy for Bone Metastases
Concurrent Xeloda and Radiotherapy for Bone Metastases

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Solid Tumors
  • Bone Metastases
  • Drug: Xeloda
  • Procedure: External Beam Radiotherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Zvi Bernstein, MD 972 4 8541812 z_bernstein@rambam.health.gov.il
Israel
 
NCT00192777
BM-RT-Xeloda.CTIL
Not Provided
Not Provided
Rambam Health Care Campus
Not Provided
Principal Investigator: Kuten Abraham, Prof. Dept. of Oncology, Rambam Health Care Campus
Rambam Health Care Campus
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP