Clinical trial · Interventional
Chemoradiation for Bone Metastasis
Chemoradiation With Capecitabine for Palliation of Pain From Bone Metastasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastasis | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change from Baseline in pain score at 12 wks
- timeFrame
- 12 weeks
- description
- 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.
Secondary outcomes (1)
- measure
- Change in pain medications consupmtion at 12 weeks compared to basline
- timeFrame
- 12 weeks
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient must be 18 years of age or older 2. The patient must have histologically proven breast adenocarcinoma 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 receiving systemic therapy with Capecitabine to metastatic disease (according to health basket) 6. Patients must have an estimated life expectancy of 3 months or greater 7. Patients will be eligible for treatment of multiple metastases only if these can be included in no more than two treatment sites 8. Signed study specific informed consent 9. Karnofsky Performance Status \> 40 10. Calculated Creatinine Clearance \> 50 ml/min 11. ALT and AST no greater than 3 5 times the institutional normal; bilirubin and serum creatinine no greater than 1.5 times normal; ANC greater than 1500, and platelets at least 100,00 Exclusion Criteria: 1. Prior radiation therapy or prior palliative surgery to the painful site 2. Impending fracture of the treatment site or planned surgical fixation of the bone 3. Patients with clinical or radiographic evidence of spinal cord or cauda equina compression 4. Patients receiving systemic radionuclides (strontium, samarium, etc.) within 60 days prior to registration
References
Publications (1)
- DERIVEDKundel Y, Nasser NJ, Purim O, Yerushalmi R, Fenig E, Pfeffer RM, Stemmer SM, Rizel S, Symon Z, Kaufman B, Sulkes A, Brenner B. Phase II study of concurrent capecitabine and external beam radiotherapy for pain control of bone metastases of breast cancer origin. PLoS One. 2013 Jul 10;8(7):e68327. doi: 10.1371/journal.pone.0068327. Print 2013. PMID 23874586