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DESCARTES

  • Open

BOOG 2022-02

General Information

BOOG number

BOOG 2022-02

Nickname

DESCARTES

Status

  • Open
Date: 22/06/2022

Full title

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

192
Date: 07/02/2024

Estimated study completion date

01/05/2032

Number of active sites

41

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: 020-5128019

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.

Regulatory Information

CCMO approval

Not applicable
Nr: NL79099.031.21
METC approval:
Yes
METC: Nederlands Kanker Instituut
NUMBER: METC21.1046/M21CAR
Date: 27/01/2022
Amendments:
Yes
Date Last Amendment: 13/12/2023

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