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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

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 24, 2009
Last Update Posted Date June 3, 2015
Study Start Date  ICMJE July 2009
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
acute moist desquamation [ Time Frame: weekly during radiotherapy and 1 month after radiotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00887523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2009)
  • Acute skin toxicity other than moist desquamation [ Time Frame: weekly during radiotherapy and 1 month after radiotherapy ]
  • Late skin toxicity [ Time Frame: at 6, 12, 18 and 24 months after radiotherapy ]
  • skin and lung fibrosis assessed with computed tomography [ Time Frame: before radiotherapy and 1 month and 1 year after radiotherapy ]
  • Quality of life [ Time Frame: at 1 year and 2 years after radiotherpay ]
  • dose-volume parameters [ Time Frame: of planning ]
  • time of treatment delivery [ Time Frame: daily during radiotherapy ]
  • single nucleotide polymorphisms associated with skin toxicity and breast fibrosis [ Time Frame: 1 blood sample before radiotherapy ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
  • Acute skin toxicity other than moist desquamation [ Time Frame: weekly during radiotherapy and 1 month after radiotherapy ]
  • Late skin toxicity [ Time Frame: at 6, 12, 18 and 24 months after radiotherapy ]
  • skin and lung fibrosis assessed with computed tomography [ Time Frame: before radiotherapy and 1 month and 1 year after radiotherapy ]
  • Quality of life [ Time Frame: at 1 year and 2 years after radiotherpay ]
  • dose-volume parameters of planning
  • time of treatment delivery [ Time Frame: daily during radiotherapy ]
  • single nucleotide polymorphisms associated with skin toxicity and breast fibrosis [ Time Frame: 1 blood sample before radiotherapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Carcinoma
Intervention  ICMJE
  • Behavioral: radiation in prone position
    radiation in prone position
  • Behavioral: radiation in supine position
    radiation in supine position
Study Arms  ICMJE
  • Experimental: 1
    prone intensity-modulated radiotherapy
    Intervention: Behavioral: radiation in prone position
  • Active Comparator: 2
    supine intensity-modulated radiotherapy
    Intervention: Behavioral: radiation in supine position
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2009)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00887523
Other Study ID Numbers  ICMJE 2009/184
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE National Cancer Plan, France
Investigators  ICMJE
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP