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Concurrent Xeloda and Radiotherapy for Bone Metastases

Phase 2
18 Years
Open (Enrolling)
Solid Tumors, Bone Metastases

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Trial Information

Concurrent Xeloda and Radiotherapy for Bone Metastases

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The frequency of pain relief for the proposed regimen, using a scale that takes into account the subjective feeling and the use of analgesics

Outcome Time Frame:

after 3 months

Principal Investigator

Kuten Abraham, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Oncology, Rambam Health Care Campus


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

November 2004

Completion Date:

Related Keywords:

  • Solid Tumors
  • Bone Metastases
  • Solid Tumors
  • Bone Metastases
  • Radiotherapy
  • Xeloda
  • Concurrent
  • Radiosensitization
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases