Studieoverzicht - 2010-03 RAPCHEM

 
Number 2010-03 RAPCHEM
Nickname RAPCHEM
Status Follow up Date: 01-02-2017
Inclusion closed
Other study number(s)
Participating parties/groups LPRM
Full title Radiotherapy After Primary CHEMotherapy for cT1-2pN+M0 breast cancer.: a multicentre prospective cohort study.
Phase and type Observational
Age ≥18
Menopausal status Not applicable
Indication Locoregional
Subindication Not applicable
Target sample size 860
Actual accrual 860 Date: 01-02-2017
Estimated study completion date 01-02-2017
CCMO approval Not applicable Date: Nr:
EudraCT nr. Not applicable
Trial Register
METC approval Not applicable Date: METC: Nr:
Amendments Date:
KWF-CKS approval Yes Date: 02-03-2010 Nr: 2010-4679
News item
Website http://www.boogstudycenter.nl
Sponsor BOOG
Principal Investigator(s) L.J. Boersma, A. Voogd, P. Elkhuizen
Study manager A.E. van Leeuwen-Stok
Central datamanagement and randomization
Monitoring
Local datamanagement
Funding Logo KWF.jpgFunding by KWF
Extra

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
Main eligibility criteria:
  • cT1-2pN+(excluding >=cN2) and at least three cycles of neoadjuvant chemotherapy followed by breast and axillary surgery
Documents (public):
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