Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase III Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)

Conditions
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Breast Cancer, Carcinoma in Situ of the Breast

Intervention / Treatment
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* Radiation: standard fractionated radiotherapy
* Radiation: hypofractionated radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: operated with breast conserving strategy for: invasive breast cancer, pT1-2, pN0-1mi, M0 OR carcinoma in situ of the breast Exclusion Criteria: previous radiation of the breast/thorax breast implants pregnant/lactating comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years

Ages Eligible for Study
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Minimum Age: 41 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 |
| --- | --- |
| Active Comparator: standard fractionated radiotherapy<br>50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week | Radiation: standard fractionated radiotherapy<br>* standard fractionated radiotherapy 50 Gy/25 fractions<br>|
| Experimental: hypofractionated radiotherapy<br>hypofractionated radiotherapy 40 Gy/15 fractions | Radiation: hypofractionated radiotherapy<br>* hypofractionated radiotherapy 40 Gy/15 fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 2 or 3 fibrosis 3 years after radiotherapy |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival |  | 10 years |