A randomised Phase III Study of Radiation Doses and Fractionation Schedules for Ductal Carcinoma in Situ (DCIS) of the Breast
Indication
Locoregional
Subindication
Not applicable
Target sample size
1600
Actual accrual
1608 (NL 186)
Date: 07/07/2014
Estimated study completion date
31/05/2014
Contact
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
Funding
Funding by KWF
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
Eligibility Criteria
DCIS (non-low risk) treated by BCS Clinically node-negative =>18 years Female