Concurrent Xeloda and Radiotherapy for Bone Metastases

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Capecitabine

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