RAPCHEM

BOOG 2010-03

General Information

BOOG number

BOOG 2010-03

Nickname

RAPCHEM

Status

Date: 01/01/2021

Participating parties / group

LPRM

Full title

Radiotherapy After Primary CHEMotherapy for cT1-2pN+M0 breast cancer.: a multicentre prospective cohort study.

Indication

Subindication

Not applicable

Target sample size

860

Actual accrual

850
Date: 01/02/2016

Estimated study completion date

01/01/2021

Contact

Sponsor

BOOG

Principal Investigator(s)

L.J. Boersma, A. Voogd, P. Elkhuizen

Study manager

A.E. van Leeuwen-Stok

Central datamanagement and randomization

n.v.t.

Monitoring

n.v.t.

Local datamanagement

NKR

Funding

Funding by KWF

Design

Data registration study

Objectives

The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2pN+(excluding ≥cN2) breast cancer patients, treated with neo-adjuvant chemotherapy, breast surgery, and radiotherapy that is protocolised based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage). The secondary aim is to develop a risk model based on risk factors, that can be used to predict which of the patients with a cT1-2pN+(excluding ≥cN2) breast carcinoma, treated with neoadjuvant chemotherapy and surgery, have a 5 yr LRR > 8 % if radiotherapy is withheld.

Endpoints

Primary endpoint:

  • 5 yr locoregional recurrence rate

Secondary endpoints:

  • 10 year LRR, and 5, 10, and 15 yr overall survival rate
  • Correlation pre-radiotherapy factors (e.g. like age < 40 yr, response to chemotherapy, tumor size) with a high LRR

Eligibility Criteria

cT1-2pN+(excluding >=cN2) and at least three cycles of neoadjuvant chemotherapy followed by breast and axillary surgery

Regulatory Information

CCMO approval

Yes

EC approval

Not applicable

EudraCT number

Not applicable

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