Studieoverzicht - 2010-03 RAPCHEM
Number | 2010-03 RAPCHEM | ||||
Nickname | RAPCHEM | ||||
Status | Closed | Date: 01-01-2021 | |||
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 | 850 | Date: 01-02-2016 | |||
Estimated study completion date | 01-01-2021 | ||||
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 | n.v.t. | |||
Monitoring | n.v.t. | |||
Local datamanagement | NKR | |||
Funding |
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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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