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
  Purpose

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 Intervention Phase
Solid Tumors
Bone Metastases
Drug: Xeloda
Procedure: External Beam Radiotherapy
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: Concurrent Xeloda and Radiotherapy for Bone Metastases

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 20
Study Start Date: November 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00192777     History of Changes
Other Study ID Numbers: BM-RT-Xeloda.CTIL
Study First Received: September 13, 2005
Last Updated: October 5, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 15, 2014