Concurrent Xeloda and Radiotherapy for Bone Metastases | NCT00192777

Studies
Concurrent Xeloda and Radiotherapy for Bone Metastases

NCT00192777

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Oct 8, 2007Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Solid Tumors
Bone Metastases

Interventions

Xeloda
External Beam Radiotherapy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2007

Last Update Posted Date

Oct 8, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	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		after 3 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zvi Bernstein, MD	Contact	972 4 8541812		z_bernstein@rambam.health.gov.il

Overall Officials

Name	Affiliation	Role
Kuten Abraham, Prof.	Dept. of Oncology, Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus	Recruiting	Haifa		31096	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D000069287	Capecitabine

Ancestor Terms

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Xeloda	Drug
External Beam Radiotherapy	Procedure