Concurrent Xeloda and Radiotherapy for Bone Metastases

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00192777

Enrollment

Registered

2005-09-19

Start date

2004-11-30

Completion date

Unknown

Last updated

2007-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Solid Tumors

Keywords

Solid Tumors, Bone Metastases, Radiotherapy, Xeloda, Concurrent, Radiosensitization

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.

Interventions

DRUGXeloda

PROCEDUREExternal Beam Radiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. The patient must be 18 years of age or older. 2. The patient must have epithelial malignancy. 3. Radiographic evidence of bone metastasis is required. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging. 4. The patient must have pain that appears to be related to the radiographically documented metastasis. 5. Patients must have an estimated life expectancy of 3 months or greater. 6. Signed study-specific informed consent. 7. Karnofsky performance status  40. 8. Calculated creatinine clearance \> 50 ml/min

Design outcomes

Primary

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	after 3 months

Secondary

Measure	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	—
The toxicity of concurrent UFT and radiotherapy in patients with bone metastases after one year	—

Countries

Israel

Contacts

Primary ContactZvi Bernstein, MD

z_bernstein@rambam.health.gov.il972 4 8541812

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026