Comparison of Set-up Reproducibility Between Prone and Supine Intensity Modulated Radiotherapy (IMRT) for the Adjuvant Treatment of Breast Carcinoma After Lumpectomy

Breast Carcinoma Clinical Trial

Official title:

Comparison of Set-up Reproducibility Between Prone and Supine Intensity Modulated Radiotherapy (IMRT) for the Adjuvant Treatment of Breast Carcinoma After Lumpectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887692
• Other study ID #: 2009/185
• Status: Completed
• Phase: N/A
• First received: April 23, 2009
• Last updated: October 18, 2010
• Start date: July 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

10 patients will be treated alternating daily between prone and supine position for breast radiotherapy to compare set-up accuracy. Prone treatment will be given on the odds days and supine treatment on the even days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female patients

• multidisciplinary decision of adjuvant radiotherapy 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

• pregnant or breastfeeding

• 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma

Intervention

Behavioral:
• prone and supine position
patients will be treated alternating daily between prone and supine position for breast radiotherapy.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Random set-up error		daily during radiotherapy	No
Secondary	Systemic set-up error		daily during radiotherapy	No
Secondary	Respiration-related motion amplitude			No
Secondary	time of treatment delivery		daily during radiotherapy	No
Secondary	Dose-volume parameters		of planning	No

External Links

•   website of the University Hospital Ghent