Studieoverzicht - 2009-01 IRMA
| Number | 2009-01 IRMA | ||||
| Nickname | IRMA | ||||
| Status | Follow up | Date: 05-02-2019 | |||
| Inclusion closed | 05-02-2019 | ||||
| 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 | 3302 (NL 830) | Date: 05-02-2019 | |||
| 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 |
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| Monitoring | Quality assurance RT via dummy runs | |||
| Local datamanagement | IKNL | |||
| Funding |
 Funding KWF-CKS |
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| Extra | ||||
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.
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.
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
- 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
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