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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
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The purpose of the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.
The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time in general is shortened 5 days. Thus the dose levels for boost patients are:
63 Gy / 51.52 Gy / 28 fractions, 57 Gy / 50 Gy / 25 fractions, 52.2 Gy / 42.3 Gy / 18 fractions, and 45.75 Gy / 40 Gy / 15 fractions.
The primary endpoint is arm lymphedema 3 years after radiation therapy, but other late radiation morbidities will also be evaluated along with recurrence and sites of recurrence. Follow up of morbidity will continue for 10 years.
The hypothesis is that women operated for early breast cancer with indication for loco-regional radiation therapy can be offered moderately hypofractionated therapy without developing more late radiation induced morbidity compared to normofractionated radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated loco-regional RT | Experimental | 40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly |
|
| Normofractionated loco-regional RT | Active Comparator | 50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loco-regional RT | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of ipsilateral arm lymphedema | >=10% increased arm circumference compared to the other arm defines edema | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Fibrosis grade 2-3 | Breast or chest wall induration | 3 years |
| Arm range of motion | Impaired shoulder movement is present when >20 degrees difference between arms at flexion and/or abduction |
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Inclusion Criteria:
Operated for early node-positive breast cancer with indication for loco-regional breast radiotherapy
Exclusion Criteria:
Previous radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up
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| Name | Affiliation | Role |
|---|---|---|
| Lars Stenbygaard, MD | Aalborg University Hospital | Study Chair |
| Troels Bechmann, MD,PhD | Vejle Hospital | Study Chair |
| Mette Nielsen, MD | Odense University Hospital | Study Chair |
| Birgitte Offersen, MD | Aarhus University Hospital | Principal Investigator |
| Hanne Nielsen, MD | Aarhus University Hospital | Study Chair |
| Claus Kamby, MD | Rigshospitalet, Denmark | Study Chair |
| Sami Al-Rawi, MD | Naestved Hospital | Study Chair |
| Mechthild Krause, MD | Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie | Study Chair |
| Andreas Schreiber, MD | Praxis für Strahlentherapie, Dresden | Study Chair |
| Ingvil Mjaaland, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D005355 | Fibrosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 years |
| Development of dyspigmentation | Grade 2 or worse dyspigmentation compared to baseline | 3 years |
| Recurrence | Any recurrence location and time to event | 10 years |
| Development of pain in the irradiated area | Pain in the irradiated area measured on visual analog scale compared to baseline | 3 years |
| Change in sensibility | Change in sensibility in the irradiated area compared to baseline measured as yes/no | 3 years |
| Development of edema on breast / chest wall | Grade 2 or worse edema | 3 years |
| Development of telangiectasia in irradiated area | Grade 2 or worse telangiectasia | 3 years |
| Stavanger Hospital |
| Study Chair |
| Tanja Marinko, MD | Institute of Oncology Ljubljana | Study Chair |
| Carine Kirkove, MD | Radiotherapy Department Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels | Study Chair |
| Egil Blix, MD | University Hospital of North Norway, Tromsoe | Study Chair |
| Unn-Miriam Kasti | Kristiansand Hospital, Norway | Study Chair |
| D020969 | Disease Attributes |