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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

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ClinicalTrials.gov Identifier: NCT00887692
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : October 19, 2010
Sponsor:
Information provided by:
University Hospital, Ghent

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Behavioral: prone and supine position Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


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


Primary Outcome Measures :
  1. Random set-up error [ Time Frame: daily during radiotherapy ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

Additional Information:
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Responsible Party: Wilfried De Neve, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00887692     History of Changes
Other Study ID Numbers: 2009/185
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: October 19, 2010
Last Verified: October 2010

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