An interventional study of standard fractionated radiotherapy and hypofractionated radiotherapy in Breast Cancer and Carcinoma in Situ of the Breast, sponsored by Danish Breast Cancer Cooperative Group. Status unknown at 1 site in Denmark. Open to female participants aged 41 Years and older. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Danish Breast Cancer Cooperative Group · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.
The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.
The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 976 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Danish Breast Cancer Cooperative Group is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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operated with breast conserving strategy for:
Exclusion Criteria:
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
Radiation: standard fractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
Radiation: hypofractionated radiotherapy
standard fractionated radiotherapy 50 Gy/25 fractions
hypofractionated radiotherapy 40 Gy/15 fractions
Grade 2 or 3 fibrosis 3 years after radiotherapy
Time frame: 3 years
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Time frame: 10 years
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Danish Breast Cancer Cooperative Group