Chemoradiation for Bone Metastasis
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|ClinicalTrials.gov Identifier: NCT01784393|
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : February 5, 2013
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.
To determine the frequency and duration of pain relief and narcotic relief for the proposed regimen.
To determine the toxicity of concurrent Capecitabine and radiotherapy in breast cancer patients with bone metastases.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Bone Metastasis Pain||Radiation: chemoradiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chemoradiation With Capecitabine for Palliation of Pain From Bone Metastasis|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
- Change from Baseline in pain score at 12 wks [ Time Frame: 12 weeks ]Patients were asked to score their pain on a scale of 0 (no pain) to 10 (worst possible pain) before treatment and at 1, 2, 4, 8 and 12 weeks after treatment initiation.
- Change in pain medications consupmtion at 12 weeks compared to basline [ Time Frame: 12 weeks ]Consumption of analgesics was evaluated by the physician using the 5-point WHO score, as follows: level 0, no analgesics required; level 1, non-narcotic analgesics required occasionally; level 2, non-narcotic analgesics required regularly; level 3, narcotic analgesics required occasionally; level 4, narcotic analgesics required regularly
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784393
|Rabin Medical Center, Beilinson Campus|
|Petach Tikva, Israel, 49100|
|Principal Investigator:||Yulia Kundel, MD||Rabin Medical Center|