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SUPREMO

  • Follow up

BOOG 2006-03

General Information

BOOG number

BOOG 2006-03

Nickname

SUPREMO

Status

  • Follow up
Date: 30/04/2013

Inclusion closed

30/04/2013

Participating parties / group

UK MRC, SCTBG, EORTC, BIG

Other study number

BIG 2-04, E22051

Full title

Selective Use of Postoperative Radiotherapy AftEr MastectOmy

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

Contact

Sponsor

UK, EORTC

Principal Investigator(s)

N.S. Russell, A.H. Westenberg

Study manager

Nadege Gosselin

Monitoring

RT quality assurance program and PA review

Funding

Funding by KWF

Other

http://www.bigagainstbreastcancer.org/scientific-projects1/clinical-trials/big-2-04-supremo

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

Eligibility Criteria

Intermediate risk defines as: pT1N1M0, pT2N0M0 grade 3 or angioinvasion, pT2N1M0 Female

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 21/11/2006
Nr:PTC06.1588

EC

Nederlands Kanker Instituut
Amendments:
Submitted

EudraCT number

Not applicable

Trial Register

ISRCTN61145589

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