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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

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ClinicalTrials.gov Identifier: NCT00887523
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : April 24, 2009
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
National Cancer Plan, France
Information provided by (Responsible Party):
University Hospital, Ghent

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2009
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
prone intensity-modulated radiotherapy
 Behavioral: radiation in prone position
radiation in prone position
Active Comparator: 2
supine intensity-modulated radiotherapy
 Behavioral: radiation in supine position
radiation in supine position


Outcome Measures
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Primary Outcome Measures :
  1. acute moist desquamation [ Time Frame: weekly during radiotherapy and 1 month after radiotherapy ]

Secondary Outcome Measures :
  1. Acute skin toxicity other than moist desquamation [ Time Frame: weekly during radiotherapy and 1 month after radiotherapy ]
  2. Late skin toxicity [ Time Frame: at 6, 12, 18 and 24 months after radiotherapy ]
  3. skin and lung fibrosis assessed with computed tomography [ Time Frame: before radiotherapy and 1 month and 1 year after radiotherapy ]
  4. Quality of life [ Time Frame: at 1 year and 2 years after radiotherpay ]
  5. dose-volume parameters [ Time Frame: of planning ]
  6. time of treatment delivery [ Time Frame: daily during radiotherapy ]
  7. single nucleotide polymorphisms associated with skin toxicity and breast fibrosis [ Time Frame: 1 blood sample before radiotherapy ]

Eligibility Criteria
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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 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.
Contacts and Locations
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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): NCT00887523


Contacts
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Contact: Liv Veldeman liv.veldeman@uzgent.be

Locations
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Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Wilfried De Neve, MD, PhD       wilfried.deneve@uzgent.be   
Sponsors and Collaborators
University Hospital, Ghent
National Cancer Plan, France
Investigators
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Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
More Information
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Additional Information:

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00887523    
Other Study ID Numbers: 2009/184
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases