Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage 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: NCT00084539|
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : March 3, 2016
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Radiation therapy||Phase 2|
- Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer.
- Determine the long-term cosmetic result and quality of life of patients treated with this regimen.
- Determine the long-term local control in patients treated with this regimen.
OUTLINE: Patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks.
Quality of life is assessed within 1 month of starting radiotherapy, at 6 weeks after completion of radiotherapy, and then every 6 months for 5 years.
Patients are followed at 6 weeks and then every six months for 5 years.
PROJECTED ACCRUAL: A total of 37-74 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||November 2005|
Experimental: Radiation therapy
Daily 5 days per week for 4 weeks
45 Gy in 20 fractions whole breast
56 Gy in 20 fractions to boost volume
|Radiation: Radiation therapy|
- Acute toxicity by CTCAE at 6 weeks [ Time Frame: 6 weeks ]
- Quality of life as measured by the Breast Cancer Treatment Outcome Scale (BCTOS) every 6 months for 5 years [ Time Frame: every 6 months for 5 years ]
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): NCT00084539
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Penny Anderson, MD||Fox Chase Cancer Center|