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

Not Applicable

Completed

• Conditions: Breast Carcinoma
• Interventions: Behavioral: radiation in prone position; Behavioral: radiation in supine position

• Registration Number: NCT00887523
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Study Start: 2009-07
• Status Verified: 2015-06
• Primary Completion: 2021-02
• Study Completion: 2021-03-08
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	radiation in prone position	prone intensity-modulated radiotherapy
2	radiation in supine position	supine intensity-modulated radiotherapy

Primary Outcome Measures

Name	Time	Method
acute moist desquamation	weekly during radiotherapy and 1 month after radiotherapy

Secondary Outcome Measures

Name	Time	Method
time of treatment delivery	daily during radiotherapy
Quality of life	at 1 year and 2 years after radiotherpay
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
dose-volume parameters	of planning
single nucleotide polymorphisms associated with skin toxicity and breast fibrosis	1 blood sample before radiotherapy

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium