Concurrent Xeloda and Radiotherapy for Bone Metastases

October 5, 2007 updated by: Rambam Health Care Campus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Haifa, Israel, 31096
    - Recruiting
    - Rambam Health Care Campus
    - Contact:
      
      Zvi Bernstein, MD
      
      Phone Number: 972 4 8541812
      
      Email: z_bernstein@rambam.health.gov.il
    - Sub-Investigator:
      
      Zvi Bernstein, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

Principal Investigator: Kuten Abraham, Prof., Dept. of Oncology, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria