Back to resultsConcurrent Xeloda and Radiotherapy for Bone Metastases
Primary Purpose
Solid Tumors, Bone Metastases
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Xeloda
External Beam Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumors focused on measuring Solid Tumors, Bone Metastases, Radiotherapy, Xeloda, Concurrent, Radiosensitization
Eligibility 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
Sites / Locations
- Rambam Health Care CampusRecruiting
Outcomes
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
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
Full Information
NCT ID
NCT00192777
First Posted
September 13, 2005
Last Updated
October 5, 2007
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT00192777
Brief Title
Concurrent Xeloda and Radiotherapy for Bone Metastases
Official Title
Concurrent Xeloda and Radiotherapy for Bone Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Bone Metastases
Keywords
Solid Tumors, Bone Metastases, Radiotherapy, Xeloda, Concurrent, Radiosensitization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Xeloda
Intervention Type
Procedure
Intervention Name(s)
External Beam Radiotherapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The duration of pain relief and narcotic relief for the proposed regimen after one year
Title
The frequency of narcotic relief for the proposed regimen after one year
Title
The toxicity of concurrent UFT and radiotherapy in patients with bone metastases after one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zvi Bernstein, MD
Phone
972 4 8541812
Email
z_bernstein@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuten Abraham, Prof.
Organizational Affiliation
Dept. of Oncology, Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zvi Bernstein, MD
Phone
972 4 8541812
Email
z_bernstein@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Zvi Bernstein, MD
12. IPD Sharing Statement
Learn more about this trial
Concurrent Xeloda and Radiotherapy for Bone Metastases
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