Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis

Study Overview
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Brief Summary
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84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.

Official Title
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Randomized Controlled Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Behavioral: radiation in prone position
* Behavioral: radiation in supine position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer minimum 18 years informed consent obtained, signed and dated before specific protocol procedures Exclusion Criteria: mastectomy need for axillary irradiation bilateral breast irradiation previous irradiation at the same time mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

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: 1<br>prone intensity-modulated radiotherapy | Behavioral: radiation in prone position<br>* radiation in prone position<br>|
| Active Comparator: 2<br>supine intensity-modulated radiotherapy | Behavioral: radiation in supine position<br>* radiation in supine position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute moist desquamation |  | weekly during radiotherapy and 1 month after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute skin toxicity other than moist desquamation |  | weekly during radiotherapy and 1 month after radiotherapy | 
| Late skin toxicity |  | at 6, 12, 18 and 24 months after radiotherapy | 
| skin and lung fibrosis assessed with computed tomography |  | before radiotherapy and 1 month and 1 year after radiotherapy | 
| Quality of life |  | at 1 year and 2 years after radiotherpay | 
| dose-volume parameters |  | of planning | 
| time of treatment delivery |  | daily during radiotherapy | 
| single nucleotide polymorphisms associated with skin toxicity and breast fibrosis |  | 1 blood sample before radiotherapy |