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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00887692
First received: April 23, 2009
Last updated: October 18, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Breast Carcinoma
Behavioral: prone and supine position

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Set-up Reproducibility Between Prone and Supine Intensity Modulated Radiotherapy (IMRT) for the Adjuvant Treatment of Breast Carcinoma After Lumpectomy

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Random set-up error [ Time Frame: daily during radiotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systemic set-up error [ Time Frame: daily during radiotherapy ] [ Designated as safety issue: No ]
  • Respiration-related motion amplitude [ Designated as safety issue: No ]
  • time of treatment delivery [ Time Frame: daily during radiotherapy ] [ Designated as safety issue: No ]
  • Dose-volume parameters [ Time Frame: of planning ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: prone and supine position
    patients will be treated alternating daily between prone and supine position for breast radiotherapy.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887692

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Wilfried De Neve, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00887692     History of Changes
Other Study ID Numbers: 2009/185
Study First Received: April 23, 2009
Last Updated: October 18, 2010
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 17, 2014