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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

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
National Cancer Plan, France
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00887523
First received: April 23, 2009
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Breast Carcinoma
 Behavioral: radiation in prone position
Behavioral: radiation in supine position

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • acute moist desquamation [ Time Frame: weekly during radiotherapy and 1 month after radiotherapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acute skin toxicity other than moist desquamation [ Time Frame: weekly during radiotherapy and 1 month after radiotherapy ] [ Designated as safety issue: Yes ]
  • Late skin toxicity [ Time Frame: at 6, 12, 18 and 24 months after radiotherapy ] [ Designated as safety issue: Yes ]
  • skin and lung fibrosis assessed with computed tomography [ Time Frame: before radiotherapy and 1 month and 1 year after radiotherapy ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: at 1 year and 2 years after radiotherpay ] [ Designated as safety issue: No ]
  • dose-volume parameters [ Time Frame: of planning ] [ Designated as safety issue: No ]
  • time of treatment delivery [ Time Frame: daily during radiotherapy ] [ Designated as safety issue: No ]
  • single nucleotide polymorphisms associated with skin toxicity and breast fibrosis [ Time Frame: 1 blood sample before radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: July 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887523

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

Locations
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
Principal Investigator: Wilfried De Neve, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00887523     History of Changes
Other Study ID Numbers: 2009/184
Study First Received: April 23, 2009
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013