Studieoverzicht - 2006-03 SUPREMO
| Number | 2006-03 SUPREMO | ||||
| Nickname | SUPREMO | ||||
| Status | Follow up | Date: 30-04-2013 | |||
| Inclusion closed | 30-04-2013 | ||||
| Other study number(s) | BIG 2-04, E22051 | ||||
| Participating parties/groups | UK MRC, SCTBG, EORTC, BIG | ||||
| Full title | Selective Use of Postoperative Radiotherapy AftEr MastectOmy | ||||
| Phase and type | Randomized Phase III | ||||
| Age | ≥ 18 | ||||
| Menopausal status | Not applicable | ||||
| Indication | Locoregional | ||||
| Subindication | Not applicable | ||||
| Target sample size | 1680 | ||||
| Actual accrual | 1688 (NL 178) | Date: 30-04-2013 | |||
| Estimated study completion date | 01-04-2011 | ||||
| CCMO approval | Not applicable | Date: | Nr: | ||
| EudraCT nr. | Not applicable | ||||
| Trial Register | ISRCTN61145589 | ||||
| METC approval | Yes | Date: 21-11-2006 | METC: Nederlands Kanker Instituut | Nr: PTC06.1588 | |
| Amendments | Submitted | Date: | |||
| KWF-CKS approval | Yes | Date: 11-10-2006 | Nr: | ||
| News item | |||||
| Website | http://www.bigagainstbreastcancer.org/scientific-projects1/clinical-trials/big-2-04-supremo | ||||
| Sponsor | UK, EORTC | ||||
| Principal Investigator(s) | N.S. Russell, A.H. Westenberg | |||
| Study manager | Nadege Gosselin | |||
| Central datamanagement and randomization | ||||
| Monitoring | RT quality assurance program and PA review | |||
| Local datamanagement | ||||
| Funding |
 Funding by KWF |
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| Extra | ||||
Design:
Randomization:
Chest wall irradiation
No chest wall irradiation
Objectives:
To determine the effect of ipsilateral chest wall irradiation following mastectomy and axillary clearance for women with operable breast cancer at ‘intermediate risk' of loco-regional recurrence.
Endpoints:
Primary endpoint:
- Overall survival
Secondary endpoints:
- Chest wall recurrence
- Regional recurrence
- Disease free survival
- Metastasis free survival
- Cause of death
- Acute and late morbidity
- Quality of life
- Cost effectiveness
Main eligibility criteria:
- Intermediate risk defines as: pT1N1M0, pT2N0M0 grade 3 or angioinvasion, pT2N1M0
- Female
Documents (public):
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