Status:

COMPLETED

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

Lead Sponsor:

University Hospital, Ghent

Collaborating Sponsors:

National Cancer Plan, France

Conditions:

Breast Carcinoma

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 8 2021

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00887523

Start Date

July 1 2009

End Date

March 8 2021

Last Update

December 20 2022

Active Locations (1)

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1

University Hospital Ghent

Ghent, Belgium, 9000