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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00977379 |
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Date of registration:
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14/09/2009 |
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Primary sponsor: |
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Public title:
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XERAD: A Study of Xeloda (Capecitabine) Plus Radiotherapy in Patients With Breast Cancer With Newly Diagnosed Brain Metastases
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Scientific title:
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XERAD: Open-label, Phase II, Randomized, Comparative, Multicentre Trial of Concurrent Whole Brain Radiation Therapy (WBRT) and Capecitabine (Xeloda® ) Followed by Maintenance Capecitabine Compared With Standard WBRT in Breast Cancer Patients With Newly Diagnosed Brain Metastasis |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00977379 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- women >/= 18 years of age
- histologically confirmed breast cancer with known HER2 and hormone status
- newly diagnosed CNS metastasis with at least one measurable (>/=0.5cm) lesion
- patient not eligible or refusing surgery or stereotactic radiosurgery
- EOCG performance status 0-2
Exclusion Criteria:
- prior treatment of brain metastases
- prior disease progression or appearance of brain metastases while on treatment with
capecitabine
- leptomeningeal disease
- known contra-indication to radiotherapy or MRI or capecitabine
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: capecitabine [Xeloda]
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Drug: systemic therapy
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Radiation: WBRT
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Primary Outcome(s)
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Best objective CNS response (CR+PR) assessed by contrast-enhanced MRI reviewed by centralized independent expert
[Time Frame: MRI 6 weeks after 1st day of radiotherapy and every 9 weeks thereafter]
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Secondary Outcome(s)
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Best objective CNS response (CR+PR), clinical benefit (CR+PR+stable disease), duration of CNS response, brain progression-free survival
[Time Frame: assessed 6 weeks after 1st day of radiotherapy and every 9 weeks thereafter or at time of clinical deterioration]
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Extracranial disease response rate according to RECIST criteria
[Time Frame: assessed after 6 weeks and every 9 weeks thereafter]
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Objective CNS response (CR+PR) assessed by MRI 4 weeks after completion of WBRT
[Time Frame: 6 weeks after 1st day of radiotherapy]
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progression-free survival (CNS or extracranial), overall survival
[Time Frame: assessed every 9 weeks or at time of clinical deterioration and by the end of the study]
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Safety, AEs
[Time Frame: throughout study, laboratory and neurological assessments every 3 weeks]
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Secondary ID(s)
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2008-007349-30
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ML21873
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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