Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIRRO IP030209 | |||
| The Danish Cancer Society |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard fractionated radiotherapy | Active Comparator | 50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week |
|
| hypofractionated radiotherapy | Experimental | hypofractionated radiotherapy 40 Gy/15 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard fractionated radiotherapy | Radiation | standard fractionated radiotherapy 50 Gy/25 fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade 2 or 3 fibrosis 3 years after radiotherapy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival | 10 years |
Not provided
Inclusion Criteria:
operated with breast conserving strategy for:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lars Stenbygaard, MD | Aalborg University Hospital | Study Chair |
| Birgitte Offersen, MD, Ph.D | Aarhus University Hospital | Study Chair |
| Erik Jakobsen, MD | Vejle Hospital | Study Chair |
| Mette H Nielsen, MD, phd | Odense University Hospital | Study Chair |
| Birgitte Offersen, MD, phd | Aarhus University Hospital | Principal Investigator |
| Mechthild Krause, M.D., Prof | University Clinic Carl Gustav Carus Dresden | Study Chair |
| Andreas Schreiber, M.D., Ph.D. | Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt | Study Chair |
| Ingvil Mjaaland, M.D. | Helse Stavanger HF, Sorlandet Sykehus HF | Study Chair |
| Unn-Miriam Kasti, M.D. | Kristiansand Sykehus | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Danish Breast Cancer Cooperative Group | Copenhagen | DK-2100 Ø | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32910709 | Derived | Offersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Krause M, Stenbygaard L, Mjaaland I, Schreiber A, Kasti UM, Overgaard J; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial. J Clin Oncol. 2020 Nov 1;38(31):3615-3625. doi: 10.1200/JCO.20.01363. Epub 2020 Sep 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| hypofractionated radiotherapy | Radiation | hypofractionated radiotherapy 40 Gy/15 fractions |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided