Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00599989|
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : April 9, 2020
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Long-term Effects Secondary to Cancer Therapy in Adults Skin Reactions Secondary to Radiation Therapy||Procedure: adjuvant therapy Procedure: conventional surgery Radiation: 3-dimensional conformal radiation therapy Radiation: brachytherapy Radiation: intracavitary balloon brachytherapy Radiation: proton beam radiation therapy||Not Applicable|
- To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.
- To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.
- To summarize the institutional experience of these patients treated with this experimental therapy.
OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).
After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accelerated Partial Breast Irradiation|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||May 11, 2009|
|Actual Study Completion Date :||May 11, 2009|
Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Radiation: intracavitary balloon brachytherapy
Radiation: proton beam radiation therapy
- Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy [ Time Frame: 11 months ]
- Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up [ Time Frame: 11 months ]
- Site of disease recurrence (i.e., local, regional, or distant) [ Time Frame: 11 months ]
- Time to recurrence [ Time Frame: 11 months ]
- Time to locoregional recurrence [ Time Frame: 11 months ]
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): NCT00599989
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Principal Investigator:||Lilie Lin, MD||Abramson Cancer Center of the University of Pennsylvania|