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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:
ClinicalTrials.gov Identifier:
NCT00887692
First Posted: April 24, 2009
Last Update Posted: October 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Systemic set-up error [ Time Frame: daily during radiotherapy ]
  • Respiration-related motion amplitude
  • time of treatment delivery [ Time Frame: daily during radiotherapy ]
  • Dose-volume parameters [ Time Frame: of planning ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Wilfried De Neve, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00887692     History of Changes
Other Study ID Numbers: 2009/185
First Submitted: April 23, 2009
First Posted: April 24, 2009
Last Update Posted: October 19, 2010
Last Verified: October 2010

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