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

31/12/2025

Contact

Sponsor

BOOG

Principal Investigator(s)

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

Study manager

A.E. van Leeuwen-Stok

Central datamanagement and registration

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

Public Downloads

Downloads

Inloggen