Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer
|ClinicalTrials.gov Identifier: NCT01417286|
Recruitment Status : Active, not recruiting
First Posted : August 16, 2011
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Breast Cancer Invasive Ductal Breast Carcinoma Invasive Lobular Breast Carcinoma Mucinous Ductal Breast Carcinoma Papillary Ductal Breast Carcinoma Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Tubular Ductal Breast Carcinoma||Radiation: External beam radiation therapy||Phase 2|
I. Freedom from local failure and freedom from regional failure.
I. Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy.
III. To correlate toxicity, cosmesis, and local control with molecular markers.
Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Radiation Therapy
Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiation: External beam radiation therapy
Hypofractionated accelerated radiation therapy over 11 days
Other Name: EBRT
- Time to local, regional, and/or distant failure [ Time Frame: Up to 5 years after dose of last treatment ]Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.
- Number and grade of adverse events experienced by patients [ Time Frame: Up to 5 years after last dose of treatment ]Adverse events will be monitored weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.
- Number of patients requiring a surgical revision of their reconstruction [ Time Frame: Up to 5 years after dose of last treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417286
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, Utah|
|Huntsman Cancer Hospital|
|Salt Lake City, Utah, United States, 84103|
|Principal Investigator:||Bruce Haffty, MD||Rutgers Cancer Institute of New Jersey|