Fibrosis, Lymphedema
Conditions
Keywords
Radiation induced morbidity, recurrence
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONLoco-regional RT
Sponsors
Danish Cancer Society
Danish Breast Cancer Cooperative Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of ipsilateral arm lymphedema | 3 years | \>=10% increased arm circumference compared to the other arm defines edema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arm range of motion | 3 years | Impaired shoulder movement is present when \>20 degrees difference between arms at flexion and/or abduction |
| Development of dyspigmentation | 3 years | Grade 2 or worse dyspigmentation compared to baseline |
| Recurrence | 10 years | Any recurrence location and time to event |
| Fibrosis grade 2-3 | 3 years | Breast or chest wall induration |
| Change in sensibility | 3 years | Change in sensibility in the irradiated area compared to baseline measured as yes/no |
| Development of edema on breast / chest wall | 3 years | Grade 2 or worse edema |
| Development of telangiectasia in irradiated area | 3 years | Grade 2 or worse telangiectasia |
| Development of pain in the irradiated area | 3 years | Pain in the irradiated area measured on visual analog scale compared to baseline |
Countries
Denmark
Outcome results
None listed