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 |
 Funding by KWF |
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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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