Concurrent Xeloda and Radiotherapy for Bone Metastases

This study is currently recruiting participants.

Verified by Rambam Health Care Campus, September 2005

First Received: September 13, 2005 Last Updated: October 5, 2007 History of Changes

Sponsored by:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00192777

Purpose

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	Intervention	Phase
Solid Tumors Bone Metastases	Drug: Xeloda Procedure: External Beam Radiotherapy	Phase II

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Concurrent Xeloda and Radiotherapy for Bone Metastases

Further study details as provided by Rambam Health Care Campus:

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 [ Time Frame: 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

Estimated Enrollment:	20
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192777

Contacts

Contact: Zvi Bernstein, MD

972 4 8541812

z_bernstein@rambam.health.gov.il

Locations

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

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator:

Kuten Abraham, Prof.

Dept. of Oncology, Rambam Health Care Campus

More Information

No publications provided

Study ID Numbers:	BM-RT-Xeloda.CTIL
Study First Received:	September 13, 2005
Last Updated:	October 5, 2007
ClinicalTrials.gov Identifier:	NCT00192777 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

Solid Tumors
Bone Metastases
Radiotherapy

Xeloda
Concurrent
Radiosensitization

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Musculoskeletal Diseases
Bone Neoplasms

Hematologic Diseases
Neoplasm Metastasis
Bone Marrow Diseases
Bone Diseases

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Bone Neoplasms
Antineoplastic Agents
Hematologic Diseases
Bone Diseases
Pharmacologic Actions

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Musculoskeletal Diseases
Therapeutic Uses
Neoplasm Metastasis
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 07, 2009