NCT01784393

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
Last Updated

February 5, 2013

Status Verified

April 1, 2007

Enrollment Period

2.9 years

First QC Date

January 14, 2013

Last Update Submit

February 3, 2013

Conditions

Breast CancerBone MetastasisPain

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in pain score at 12 wks

    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.

    12 weeks

Secondary Outcomes (1)

  • Change in pain medications consupmtion at 12 weeks compared to basline

    12 weeks

Interventions

chemoradiationRADIATION

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be 18 years of age or older
  • The patient must have histologically proven breast adenocarcinoma
  • Radiographic evidence of bone metastasis is required .Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging
  • The patient must have pain that appears to be related to the radiographically documented metastasis
  • Patients receiving systemic therapy with Capecitabine to metastatic disease (according to health basket)
  • Patients must have an estimated life expectancy of 3 months or greater
  • Patients will be eligible for treatment of multiple metastases only if these can be included in no more than two treatment sites
  • Signed study specific informed consent
  • Karnofsky Performance Status \> 40
  • Calculated Creatinine Clearance \> 50 ml/min
  • 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

You may not qualify if:

  • Prior radiation therapy or prior palliative surgery to the painful site
  • Impending fracture of the treatment site or planned surgical fixation of the bone
  • Patients with clinical or radiographic evidence of spinal cord or cauda equina compression
  • Patients receiving systemic radionuclides (strontium, samarium, etc.) within 60 days prior to registration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Beilinson Campus

Petah Tikva, 49100, Israel

Location

Related Publications (1)

  • Kundel 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: 23874586DERIVED

MeSH Terms

Conditions

Breast NeoplasmsPain

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Yulia Kundel, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2013

First Posted

February 5, 2013

Study Start

May 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

February 5, 2013

Record last verified: 2007-04

Locations

IL(1)