Studieoverzicht - 2022-02 DESCARTES

 
 
Number 2022-02 DESCARTES
Nickname DESCARTES
Status Open Date: 22-06-2022
Inclusion closed
Other study number(s)
Participating parties/groups
Full title DESCARTES study: De-ESCAlating RadioTherapy in patients with pathologic complete response to neoadjuvant systemic therapy
Phase and type
Age ≥18
Menopausal status Both pre- and postmenopausal
Indication Locoregional
Subindication Any HER2, any HR
Target sample size 595
Actual accrual 105 Date: 16-08-2023
Estimated study completion date 01-05-2032
CCMO approval Date: Nr: NL79099.031.21
EudraCT nr.
Trial Register
METC approval Yes Date: 27-01-2022 METC: Nederlands Kanker Instituut Nr: METC21.1046/M21CAR
Amendments Yes Date: 18-07-2023
KWF-CKS approval Date: Nr:
News item
Website
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 Studiecoördinator: Josefien van Olmen, arts onderzoeker NKI-AvL
E: descartes@nki.nl of j.v.olmen@nki.nl
T: 020-5128019

Dr. S.M. van den Berg (BOOG Study Center)
Central datamanagement and randomization NKI-AVL
Monitoring NKI-AVL
Local datamanagement IKNL
Funding KWF, pink ribbon
Extra Centra open voor inclusie: Admiraal de Ruyter Ziekenhuis, Alexander Monro Ziekenhuis, Alrijne Ziekenhuis, Amphia, Antonius Zorggroep Sneek, Canisius Wilhelmina Ziekenhuis, Catharina Ziekenhuis, Deventer Ziekenhuis, Diakonessenhuis Utrecht, Flevoziekenhuis, Haaglanden Medisch Centrum, Isala, Jeroen Bosch Ziekenhuis, Leids Universitair Medisch Centrum, Maastricht UMC+, Martini Ziekenhuis, Maxima Medisch Centrum, Meander Medisch Centrum, Medisch Centrum Leeuwarden, NKI-AVL, Noordwest Ziekenhuisgroep, Onze Lieve Vrouwe Gasthuis, Reinier de Graaf Gasthuis, Rijnstate Ziekenhuis, Rivierenland Ziekenhuis Rode Kruis Ziekenhuis, Slingeland Ziekenhuis, Spaarne Gasthuis, St. Antonius Ziekenhuis, Tergooi MC, Treant, VieCuri Medisch Centrum, Zaans Medisch Centrum, Ziekenhuis Gelderse Vallei, ZorgSaam, Zuyderland Medisch Centrum

Design:

Prospective single arm multicenter national study.

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.

Main eligibility criteria:

Node-negative patients with a pathologic complete response to neoadjuvant systemic therapy who were treated with breast conserving surgery.

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