Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Skagen Trial 1, Moderately Hypofractionated Loco-regional Adjuvant Radiation Therapy of Early Breast Cancer Combined With a Simultaneous Integrated Boost: a Randomised Clinically Controlled Trial

Conditions
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Lymphedema, Fibrosis

Intervention / Treatment
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* Radiation: Loco-regional RT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated loco-regional RT<br>40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly | Radiation: Loco-regional RT<br> <br> |
| Active Comparator: Normofractionated loco-regional RT<br>50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly | Radiation: Loco-regional RT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of ipsilateral arm lymphedema | >=10% increased arm circumference compared to the other arm defines edema | 3 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation induced morbidity, recurrence