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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Breast Carcinoma

Treatments: Behavioral: radiation in supine position; Behavioral: radiation in prone position

Study type: Interventional

Funder types: Other

Identifiers

NCT00887523

2009/184

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Experimental group

Description:

prone intensity-modulated radiotherapy

Treatment:

Behavioral: radiation in prone position

2

Active Comparator group

Description:

supine intensity-modulated radiotherapy

Treatment:

Behavioral: radiation in supine position