NCT00192777

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

October 8, 2007

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

October 5, 2007

Conditions

Solid TumorsBone Metastases

Keywords

Solid TumorsBone MetastasesRadiotherapyXelodaConcurrentRadiosensitization

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • 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

Interventions

XelodaDRUG
External Beam RadiotherapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Kuten Abraham, Prof.

    Dept. of Oncology, Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zvi Bernstein, MD

CONTACT

972 4 8541812z_bernstein@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

November 1, 2004

Last Updated

October 8, 2007

Record last verified: 2005-09

Locations

IL(1)