DESCARTES study: De-ESCAlating RadioTherapy in patients with pathologic complete response to neoadjuvant systemic therapy
Indication
Locoregional
Subindication
Any HER2, any HR
Description
De-escalating radiotherapy
Target sample size
595
Actual accrual
297
Date: 13/09/2024
Estimated study completion date
01/05/2032
Number of active sites
42
Contact
Sponsor
NKI-AVL
Principal Investigator(s)
dr. Frederieke van Duijnhoven (NKI-AvL)
dr. John Maduro (UMCG)
prof. dr. Marie-Jeanne Vrancken Peeters (NKI-AvL)
dr. Jolien Tol (JBZ)
prof. dr. Liesbeth Boersma (MAASTRO clinic)
dr. Nicola Russell (NKI-AvL)
Study manager
Dr. S.M. van den Berg (BOOG Study Center)
Study coordinator
Josefien van Olmen
arts onderzoeker NKI-AvL
descartes@nki.nl of j.v.olmen@nki.nl
T: 020-512 4144
Central datamanagement and randomization
NKI-AVL
Monitoring
NKI-AVL
Local datamanagement
IKNL
Funding
KWF, pink ribbon
Design
Prospective single arm multicenter national study.
Participating sites
Objectives
To show that omitting radiotherapy in patients with a pCR to NST results in an excellent 5 year local control rate.
Endpoints
The primary endpoint is the 5-year local recurrence rate. Secondary endpoints include local non-salvageable recurrence free survival, quality of life, cancer worry, regional recurrence, distant recurrence free survival, disease-specific survival and overall survival.
Eligibility Criteria
Node-negative patients with a pathologic complete response to neoadjuvant systemic therapy who were treated with breast conserving surgery.