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NCT00192777 Clinical Trial

Concurrent Xeloda and Radiotherapy for Bone Metastases

Solid Tumors Clinical Trial

Official title:
Concurrent Xeloda and Radiotherapy for Bone Metastases

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00192777
Other study ID # BM-RT-Xeloda.CTIL
Secondary ID
Status Recruiting
Phase Phase 2
First received September 13, 2005
Last updated October 5, 2007
Start date November 2004

Study information
Verified date September 2005
Source Rambam Health Care Campus
Contact Zvi Bernstein, MD
Phone 972 4 8541812
Email z_bernstein@rambam.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Xeloda

Procedure:
• External Beam Radiotherapy

Locations
Country Name City State
Israel Rambam Health Care Campus Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 The duration of pain relief and narcotic relief for the proposed regimen after one year
Secondary The frequency of narcotic relief for the proposed regimen after one year
Secondary The toxicity of concurrent UFT and radiotherapy in patients with bone metastases after one year
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