Studieoverzicht - 2016-01 TOP-1
| Number | 2016-01 TOP-1 | ||||
| Nickname | TOP-1 | ||||
| Status | Open | Date: 01-04-2016 | |||
| Inclusion closed | |||||
| Other study number(s) | |||||
| Participating parties/groups | |||||
| Full title | Tailored treatment in Older Patients TOP-1: Omission of radiotherapy in elderly patients with low risk breast cancer | ||||
| Phase and type | Observational | ||||
| Age | > 70 | ||||
| Menopausal status | Postmenopausal | ||||
| Indication | Data registration | ||||
| Subindication | HER2- HR+ | ||||
| Target sample size | 800 | ||||
| Actual accrual | 567 | Date: 01-01-2021 | |||
| Estimated study completion date | |||||
| CCMO approval | Date: | Nr: | |||
| EudraCT nr. | |||||
| Trial Register | |||||
| METC approval | Yes | Date: 24-11-2016 | METC: Leiden Universitair Medisch Centrum | Nr: | |
| Amendments | Yes | Date: 08-02-2018 | |||
| KWF-CKS approval | Yes | Date: 18-12-2015 | Nr: TDM-Hi/8o5G | ||
| News item | |||||
| Website | https://www.boogstudycenter.nl/studie/283/top-1.html , voor patienten: https://www.kanker.nl/trials/795-boog-2016-01-top-1-borstkanker | ||||
| Sponsor | Leids Universitair Medisch Centrum | ||||
| Principal Investigator(s) | G.J. Liefers, MD, PhD (LUMC) | |||
| Study manager | J. Braak (datacenter LUMC) E. van Leeuwen-Stok (BOOG sc) |
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| Central datamanagement and randomization | Datacenter Heelkunde, LUMC, Ir. W.M. Meershoek - Klein Kranenbarg & Ing. J.P.B.M. Braak J-10-070, K6-R Postbus 9600 2300 RC Leiden, The Netherlands ClinicalResearchCenter@lumc.nl ClinicalResearchCenter@lumc.nl. | 003171-5263500 |
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| Monitoring | ||||
| Local datamanagement | Door het IKNL (alleen NKI zelf) |
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| Funding | KWF | |||
| Extra | ||||
Primary Objective: To determine if radiotherapy (RT) can safely be omitted after breast
conserving surgery (BCS) in elderly patients at low risk of developing a local recurrence (LR)
Secondary objectives: assessment of: quality of life, toxicity, geriatric assessment, overall- and
breast cancer specific survival, distant metastasis free survival, relating biomarkers to
outcome (tumor characteristics, at least: IHC ER, PR, HER2 and Ki-67), additional state of
the art molecular analysis if possible, development and validation of local recurrence rate
prediction models, (cost) efficacy (comparison with historical control group) and
implementation of findings into standard care.
Primary endpoints: the local recurrence rate (LRR)
at 5 years. Secondary endpoint: distant metastases free survival (DMFS), breast
cancer-specific survival (BCSS) and overall survival (OS), quality of life, side-effects, costs,
cosmetic outcome, geriatric assessment and biomarkers.
Inclusion criteria:
- age 70 years or older;
- within 3 months after BCS;
- tumor <1 cm grade 1-2 or tumor 1-2cm grade 1;
- tumor ER>50% positive, HER2 negative;
- sN0 or sN0(itc);
- R0 resection;
- female.
Exclusion criteria:
- Indication for hormornal therapy;
- Bilateral
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