Studieoverzicht - 2009-03 DCIS

 
Number 2009-03 DCIS
Nickname DCIS
Status Follow up Date: 22-06-2014
Inclusion closed 22-06-2014
Other study number(s) TROG 07.01, BIG 3-07, KWF 4467
Participating parties/groups TROG, EORTC, BIG
Full title A randomised Phase III Study of Radiation Doses and Fractionation Schedules for Ductal Carcinoma in Situ (DCIS) of the Breast
Phase and type Randomized Phase III
Age ≥ 18
Menopausal status Not applicable
Indication Locoregional
Subindication Not applicable
Target sample size 1600
Actual accrual 1608 (NL 182) Date: 07-07-2014
Estimated study completion date 31-05-2014
CCMO approval Not applicable Date: Nr:
EudraCT nr. Not applicable
Trial Register
METC approval Yes Date: 30-09-2009 METC: CMO Regio Arnhem-Nijmegen Nr: NL28754.091.09 (2009/197)
Amendments Yes Date: 21-06-2012
KWF-CKS approval Yes Date: 02-07-2009 Nr: 2010-4467
News item
Website http://www.bigagainstbreastcancer.org/scientific-projects1/clinical-trials/big-3-07-dcis
Sponsor TROG (EORTC for NL)
Principal Investigator(s) A.H. Westenberg
Study manager A.E. van Leeuwen-Stok
Central datamanagement and randomization TROG Trial Centre
fax +61 396561420
email Janani.Sivasuthan@petermac.org
Monitoring QART
Local datamanagement
Funding Logo KWF.jpgFunding by KWF
Extra

Design:

Randomisation B:
Arm 1: Whole breast RT alone using standard fractionation
Arm 3: Whole breast RT using standard fractionation plus tumour bed boost  

Or Randomisation C:
Arm 2: Whole breast RT alone using shorter fractionation ;
Arm 4: Whole breast RT using shorter fractionation plus tumour bed boost

Objectives:

To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
To evaluate time to local recurrence in women with DCIS treated with breast conserving surgery followed by: whole breast RT alone versus whole breast RT plus tumour bed boost; RT using the standard fractionation schedule versus the shorter schedule.

Endpoints:

Primar endpoint:

  • Time to local recurrence

Secondary endpoints:

  • Overall survival
  • Time to disease recurrence
  • Cosmetic outcome
  • Quality of life
  • Toxicity
Main eligibility criteria:
  • DCIS (non-low risk) treated by BCS
  • Clinically node-negative
  • =>18 years
  • Female
Documents (public):

Protocol synopsis

Documents (protected):
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