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Chemoradiation for Bone Metastasis

NCT01784393 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2013-02-05

No results posted yet for this study

Summary

Pain from bone metastases of breast cancer origin is treated with localized radiation. Modulating doses and schedules has shown little efficacy in improving results. Given the synergistic therapeutic effect reported for combined systemic chemotherapy with local radiation in anal, rectal, and head and neck malignancies, the investigators sought to evaluate the tolerability and efficacy of combined capecitabine and radiation for palliation of pain due to bone metastases from breast cancer Hypothesis: Given the hypothesis that regimens employing greater intensity radiation yield higher rates of pain relief, radiosensitization using a tumor targeted drug like Xeloda should improve the rate of complete pain relief as compared to radiosensitization with 5FU alone.

Primary Objective:

To determine the frequency and duration of pain relief and narcotic relief for the proposed regimen.

Secondary Objective:

To determine the toxicity of concurrent Capecitabine and radiotherapy in breast cancer patients with bone metastases.

Conditions

Interventions

RADIATION

chemoradiation

Sponsors & Collaborators

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Yulia Kundel, MD · Rabin Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01784393 on ClinicalTrials.gov