Concurrent Xeloda and Radiotherapy for Bone Metastases

Rambam Health Care Campus

Status and phase: Unknown; Phase 2

Conditions: Solid Tumors; Bone Metastases

Treatments: Procedure: External Beam Radiotherapy; Drug: Xeloda

Study type: Interventional

Funder types: Other

Identifiers

NCT00192777

BM-RT-Xeloda.CTIL

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)