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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Breast Carcinoma

Treatments

Behavioral: radiation in supine position
Behavioral: radiation in prone position

Study type

Interventional

Funder types

Other

Identifiers

NCT00887523
2009/184

Details and patient eligibility

About

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

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

1
Experimental group
Description:
prone intensity-modulated radiotherapy
Treatment:
Behavioral: radiation in prone position
2
Active Comparator group
Description:
supine intensity-modulated radiotherapy
Treatment:
Behavioral: radiation in supine position

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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