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. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 20, 2014