Trial Information
Concurrent Xeloda and Radiotherapy for Bone Metastases
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The frequency of pain relief for the proposed regimen, using a scale that takes into account the subjective feeling and the use of analgesics
Outcome Time Frame:
after 3 months
Principal Investigator
Kuten Abraham, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dept. of Oncology, Rambam Health Care Campus
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
BM-RT-Xeloda.CTIL
NCT ID:
NCT00192777
Start Date:
November 2004
Completion Date:
Related Keywords:
- Solid Tumors
- Bone Metastases
- Solid Tumors
- Bone Metastases
- Radiotherapy
- Xeloda
- Concurrent
- Radiosensitization
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Bone Neoplasms
- Bone Marrow Diseases