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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Carcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

acute moist desquamation

Outcome Time Frame:

weekly during radiotherapy and 1 month after radiotherapy

Safety Issue:

Yes

Principal Investigator

Wilfried De Neve, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Institutional Review Board

Study ID:

2009/184

NCT ID:

NCT00887523

Start Date:

July 2009

Completion Date:

March 2013

Related Keywords:

  • Breast Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Fibrosis

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