DCIS

BOOG 2009-03

General Information

BOOG number

BOOG 2009-03

Nickname

DCIS

Status

Date: 22/06/2014

Inclusion closed

22/06/2014

Participating parties / group

TROG, EORTC, BIG

Other study number

TROG 07.01, BIG 3-07, KWF 4467

Full title

A randomised Phase III Study of Radiation Doses and Fractionation Schedules for Ductal Carcinoma in Situ (DCIS) of the Breast

Indication

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

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 30/09/2009
Nr:NL28754.091.09 (2009/197)

EC

CMO Regio Arnhem-Nijmegen
Amendments:
Yes
Date Last Amendment: 21/06/2012

EudraCT number

Not applicable

Downloads

Inloggen