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 186) | 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 |
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| Monitoring | QART | |||
| Local datamanagement | ||||
| Funding |
 Funding by KWF |
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| 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):
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