Shorter Course Radiation for the Treatment of Breast Cancer That Has Spread to Lymph Nodes
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|ClinicalTrials.gov Identifier: NCT02700386|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Combination Product: Adjuvant Hypofractionated Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypofractionated, Comprehensive Radiation Therapy for Node-Positive Breast Cancer|
|Actual Study Start Date :||August 11, 2016|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Adjuvant Hypofractionated Radiation
Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.
Combination Product: Adjuvant Hypofractionated Radiation
Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
Other Name: Radiation Therapy
- Number of participants with treatment-related adverse events as assessed by CTCAE version 4.03 [ Time Frame: Up to 60 months ]Any grade of 4 or 5 toxicity by CTCAE will qualify as a serious adverse event (SAE). Brachial plexopathy Grade 2 ('moderate symptoms; limiting instrumental activity of daily living (ADL)') or Grade 3 ('severe symptoms; limiting self-care ADL') and Grade 3 lymphedema ('Severe symptoms; limiting self-care ADL') and Grade 2 pneumonitis (requires steroids) will qualify as reportable adverse events (AE).
- Number of participants with lymphedema severity by measuring interlimb circumference [ Time Frame: Up to 60 Months ]An increase in interlimb arm circumference of at least 10% in the lower arm or the upper arm, or both, compared with the contralateral arm at the same timepoint, will be judged to be clinically significant lymphedema. Arm circumference 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms) will be measured every 6 months, up to 60 months
- Number of participants with symptomatic rib fracture as measured by plain film or CT [ Time Frame: Up to 60 Months ]Symptomatic rib fracture will be diagnosed by evidence of a correlative lesion on plain film or CT.
- Number of participants with new development of ischemic heart disease as measured by EKG [ Time Frame: Up to 60 Months ]Ischemic heart disease will be measured by the new development of angina with corresponding EKG changes, or myocardial infraction.
- Number of participants reporting shoulder stiffness as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C3014) and breast-cancer module (BR23) [ Time Frame: Up to 60 Months ]Reported by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C3014) and breast-cancer module (BR23).
- Number of participants with disease recurrence [ Time Frame: Up to 60 months ]Recurrent disease presentation within axillary lymph node levels I, II, or III. The supraclavicular region is not included in this endpoint.
- Number of participants with metastasis-free survival [ Time Frame: Up to 60 months ]Measured by the time from date of enrollment to earlier of clinical detection of metastatic disease beyond the breast/chestwall and regional lymph nodes or death.
- Number of participants with local-regional failure free survival [ Time Frame: Up to 60 months ]Measured by the time from date of enrollment to earlier of clinical detection of any ipsilateral recurrent disease to the breast/chestwall or regional lymph nodes (levels I, II, III, supraclavicular, and internal mammary lymph nodes) or death.
- Number of participants with a change in quality of life score as measured by the EORTC QLQ-C3014 and breast-cancer module (BR23) [ Time Frame: Up to 60 months ]Patient's quality of life from pre-treatment to post-treatment, reported by the quality of life questionnaire [EORTC QLQ-C3014 and breast-cancer module (BR23)].
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): NCT02700386
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Colorado Springs, Colorado, United States, 80909|
|Poudre Valley Hospital|
|Fort Collins, Colorado, United States, 80524|
|Principal Investigator:||Christine Fisher, MD, MPH||University of Colorado, Denver|