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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: |
NCT00875355 |
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Date of registration:
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02/04/2009 |
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Primary sponsor: |
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Public title:
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Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer
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Scientific title:
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Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00875355 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, 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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Youlia Kirova |
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Address:
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Telephone:
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33-44-32-4000 |
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Email:
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Affiliation:
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Name:
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Youlia Kirova |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Curie |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Unresectable disease or patient refused surgery
- Must have brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC = 1,500/mm³
- Platelet count = 100,000/mm³
- Liver transaminases = 1.5 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No carcinomatous meningitis
- No history of cancer except for basal cell carcinoma of the skin or carcinoma in situ
of the cervix
- No other serious concurrent disease that is, in the opinion of the investigator,
likely to interfere with study evaluation and treatment
- No contraindications to treatment with temozolomide
- No psychological, familial, social, or geographic situations that preclude clinical
follow up
- No patient deprived of liberty or under guardianship
PRIOR CONCURRENT THERAPY:
- No prior brain radiotherapy
- At least 10 days since prior chemotherapy
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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Metastatic Cancer
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Intervention(s)
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Drug: temozolomide
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Radiation: radiation therapy
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Primary Outcome(s)
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Response at 6 weeks as assessed by MRI and/or scan
[Time Frame: No]
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Secondary ID(s)
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CDR0000633496
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CLCC-IC-2007-01
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CLCC-IC-RT-TEMODAL
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EUDRACT-2007-002531-83
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INCA-RECF0630
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SCHER-CLCC-IC-RT-TEMODAL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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