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:
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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 Logo KWF.jpgFunding by KWF



Chest wall irradiation
No chest wall irradiation


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.


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
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