Concurrent Xeloda and Radiotherapy for Bone Metastases

Phase 2

• Conditions: Solid Tumors; Bone Metastases

• Registration Number: NCT00192777
• Lead Sponsor: Rambam Health Care Campus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Last Update Submitted: 2007-10-05
• Last Update Posted: 2007-10-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The frequency of pain relief for the proposed regimen, using a scale that takes into account the subjective feeling and the use of analgesics	after 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel