Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT00104702
Brief Summary:
RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine reproducibility of localized and concentrated adjuvant radiotherapy, in terms of isodose curve and dose heterogeneity, in older women with stage I or II breast cancer.
Secondary
* Determine the impact of this regimen on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score in these patients.
* Determine relapse-free survival of patients treated with this regimen.
* Determine overall and specific survival of patients treated with this regimen.
* Determine the cosmetic result, as assessed by the patient, surgeon, and radiologist, of this regimen in these patients.
* Determine the direct and indirect costs of this regimen in these patients.
OUTLINE: This is a multicenter, open-label, nonrandomized study.
Patients undergo surgery. After surgery, patients undergo radiotherapy twice daily for 5 days.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Study:
NCT00104702
Study Brief:
Protocol Section:
NCT00104702