Studieoverzicht - 2009-01 IRMA

 
Number 2009-01 IRMA
Nickname IRMA
Status Follow up Date: 30-03-2018
Inclusion closed 30-03-2018
Other study number(s)
Participating parties/groups PRI ER (It)
Full title IRMA study protocol. Breast cancer with low risk of local recurrence: partial and accelerated radiation with three-dimensional conformal radiotherapy (3DCRT) vs. standard radiotherapy after conserving surgery
Phase and type non-inferiority
Age > = 49
Menopausal status Not applicable
Indication Locoregional
Subindication Not applicable
Target sample size 3302
Actual accrual 3100 (NL 829) Date: 30-03-2018
Estimated study completion date 01-07-2018
CCMO approval Not applicable Date: Nr: NL 27657.028.09
EudraCT nr. Not applicable
Trial Register
METC approval Yes Date: 18-02-2010 METC: METOPP Nr: M234
Amendments Yes Date: 06-12-2009
KWF-CKS approval Yes Date: 26-03-2009 Nr: 2009-4392
News item
Website http://www.boogstudycenter.nl
Sponsor Modena University Hospital
Principal Investigator(s) Ph. Poortmans-L.J. Boersma
Study manager A.E. van Leeuwen-Stok
Central datamanagement and randomization Clinical Trials Office, University of Modena
Tel. +39 059 422 3865
roberto.vicini@unimore.it
Monitoring Quality assurance RT via dummy runs
Local datamanagement IKNL
Funding Logo KWF.jpgFunding KWF-CKS
Extra

Design:

Randomization:
Experimental arm: 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day with an interval of at least 6 hours between the two fractions, for five consecutive working days.
Control arm: 45 Gy/18 fractions, or 50 Gy/25 fractions, or 50,4 Gy/28 fractions, or iso-effective fraction schemes, once a day for 5 days a week. A 10 - 16 Gy boost is allowed in centers where it is part of the standard treatment.

Objectives:

To evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer with low risk of local recurrence and undergoing conservative surgery, is not inferior to postoperative irradiation with conventional fractionation of the entire breast as regards local control, measured in terms of incidence of ipsilateral recurrences as first event.

Endpoints:

Primary endpoint:

  • Local ipsilateral recurrence as first event free survival

Secondary endpoints:

  • Overall survival
  • Locoregional recurrence-free survival
  • Distant recurrence-free survival
  • Acute and late toxicity (RTOG) 
  • Cosmetic result
Main eligibility criteria:
  • Female,
  • pT 1-2 (< 3 cm in diameter) pN0-N1 M0
  • Unifocal
  • Histologically negative resection margins (≥ 2 mm) at first intervention or after subsequent widening
  • Undergoing conservative breast surgery for invasive breast cancer
Documents (public):
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