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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301041 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This randomized clinical trial is studying the side effects and best way to give radiation therapy and to see how well it works in treating patients with invasive breast cancer.
Condition | Intervention |
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Breast Cancer |
Procedure: adjuvant therapy Procedure: laboratory biomarker analysis Procedure: radiation therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | The Relationship Between Plasma Transforming Growth Factor-Beta 1 (TGF-β) and Fractionation in Radiotherapy for Breast Cancer: A Randomized Study |
Estimated Enrollment: | 100 |
Study Start Date: | April 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Underwent lumpectomy (breast-preserving surgery) with or without adjuvant chemotherapy within the past 12 weeks
Candidates for postoperative breast radiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 |
Principal Investigator: | Catherine C. Park, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000465214, UCSF-03756, UCSF-H11164-24300-02 |
Study First Received: | March 8, 2006 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00301041 |
Health Authority: | Unspecified |
invasive ductal breast carcinoma invasive lobular breast carcinoma stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Carcinoma, Lobular Skin Diseases Breast Neoplasms |
Carcinoma, Ductal, Breast Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site |