Concurrent Xeloda and Radiotherapy for Bone Metastases

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Unknown status

CT.gov ID

NCT00192777

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors Bone Metastases	Drug: Xeloda Procedure: External Beam Radiotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Concurrent Xeloda and Radiotherapy for Bone Metastases

Study Start Date :

Nov 1, 2004

Outcome Measures

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 [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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient must be 18 years of age or older.
The patient must have epithelial malignancy.
Radiographic evidence of bone metastasis is required. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging.
The patient must have pain that appears to be related to the radiographically documented metastasis.
Patients must have an estimated life expectancy of 3 months or greater.
Signed study-specific informed consent.
Karnofsky performance status  40.
Calculated creatinine clearance > 50 ml/min