3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
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|ClinicalTrials.gov Identifier: NCT00068263|
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : January 4, 2017
RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: radiation therapy||Phase 1 Phase 2|
- Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy confined to the region of the lumpectomy cavity in women with stage I or II breast cancer.
- Determine the cosmetic results in patients treated with this regimen.
- Determine the complication rates in patients treated with this regimen.
- Determine the local control rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery.
Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to 15.3 months.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||December 2016|
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): NCT00068263
|United States, Arizona|
|Foundation for Cancer Research and Education|
|Phoenix, Arizona, United States, 85013|
|United States, Wisconsin|
|CCOP - Marshfield Clinic Research Foundation|
|Marshfield, Wisconsin, United States, 54449|
|Study Chair:||Frank Vicini, MD, FACR||William Beaumont Hospital - Royal Oak Campus|