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A Multicentre Randomized Controlled Clinical Trial for the Reduction of Acute Skin Reaction in Adjuvant Breast Radiation in Large Breasted Women Using a Prone Technique - The Prone Breast Trial


N/A
N/A
N/A
Open (Enrolling)
Female
Ductal Carcinoma In Situ, Invasive Breast Cancer

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Trial Information

A Multicentre Randomized Controlled Clinical Trial for the Reduction of Acute Skin Reaction in Adjuvant Breast Radiation in Large Breasted Women Using a Prone Technique - The Prone Breast Trial


The risk of moist desquamation in large breasted women remains unacceptably high and
reactions tends to be severe and produce significant permanent and delayed side effects.
Evidence suggests that the use of a prone breast IMRT technique has the potential to
decrease the risk of moist desquamation in large breasted women to the levels that are now
seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT
is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes
of providing motivation for this study, a multicentre RCT is feasible to confirm and
quantify the improvement provided by the prone technique and provide Level 1 evidence for it
to be adopted world-wide.


Inclusion Criteria:



- confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ
(DCIS);

- treated with BCT;

- no indication for treatment of regional LN;

- Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or
greater

Exclusion Criteria:

- Regional Lymph Node XRT indicated;

- Bilateral breast cancer;

- unhealed wound (skin not closed and/or infection);

- previous XRT to the same breast;

- unable to lie prone;

- presence of active connective tissue disease;

- pregnancy;

- unacceptable heart exposure (as measured by > 10% of the heart receiving 50% of the
prescribed dose, i.e. V25Gy > 10%);

- adequate coverage of postoperative tumour bed not technically possible

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Moist Desquamation

Outcome Description:

Acute moist desquamation rates as measured by CTCAE 4.03 during and up to 6-8 weeks post treatment.

Outcome Time Frame:

6-8 week post-treatment.

Safety Issue:

Yes

Principal Investigator

Danny Vesprini, MD MSc FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Odette Cancer Centre

Authority:

Canada: Health Canada

Study ID:

380-2012

NCT ID:

NCT01815476

Start Date:

May 2013

Completion Date:

May 2018

Related Keywords:

  • Ductal Carcinoma In Situ
  • Invasive Breast Cancer
  • DCIS
  • Early Stage Invasive breast cancer
  • Prone breast radiotherapy
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

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