Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00875355|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : April 3, 2009
Last Update Posted : August 26, 2009
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Cancer||Drug: temozolomide Radiation: radiation therapy||Phase 2|
- Compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide.
- Evaluate the tolerability.
- Compare the duration of response.
- Compare local progression-free survival.
- Compare overall survival.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
- Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Official Title:||Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer|
|Study Start Date :||November 2007|
|Estimated Primary Completion Date :||November 2009|
Experimental: Arm I
Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
Radiation: radiation therapy
Patients undergo radiotherapy
Experimental: Arm II
Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
Given orallyRadiation: radiation therapy
Patients undergo radiotherapy
- Response at 6 weeks as assessed by MRI and/or scan
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): NCT00875355
|Institut Curie Hopital||Recruiting|
|Paris, France, 75248|
|Contact: Youlia Kirova 33-44-32-4000|
|Principal Investigator:||Youlia Kirova||Institut Curie|