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NCT00887523 Clinical Trial

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

Breast Carcinoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00887523
Other study ID # 2009/184
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2009
Est. completion date March 8, 2021

Study information
Verified date June 2015
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 8, 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• radiation in prone position
radiation in prone position
• radiation in supine position
radiation in supine position

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent National Cancer Plan, France

Country where clinical trial is conducted

Belgium, 

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