Radiotherapy (RT) can safely be omitted after breast conserving surgery (BCS) in elderly patients at low risk of developing a local recurrence (LR)
ID
Bron
Verkorte titel
Aandoening
Elderly, Breast, Cancer, Radiotherapy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary aim: to assess whether radiotherapy can be safely omitted after breast conserving surgery in elderly patients with a very low risk of local recurrence
Achtergrond van het onderzoek
The main focus of the present trial is a first step towards treatment de-escalation in older breast cancer patients.
Primary aim: to assess whether radiotherapy can be safely omitted after breast conserving surgery in elderly patients with a very low risk of local recurrence.
Secondary aim: 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.
Doel van het onderzoek
Radiotherapy (RT) can safely be omitted after breast conserving surgery (BCS) in elderly patients at low risk of developing a local recurrence (LR)
Onderzoeksopzet
The primary endpoint is the local recurrence rate (LRR) at 5 years. Secondary determinants are the distant metastases free survival (DMFS), breast cancer-specific survival (BCSS) and overall survival (OS)
Onderzoeksproduct en/of interventie
Omitting adjuvant radiotherapy
Publiek
Clinical Research Center Heelkunde LUMC
Postzone K-6-R, Postbus 9600
Leiden 2300 RC
The Netherlands
071 526 3500
ClinicalResearchCenter@lumc.nl
Wetenschappelijk
Clinical Research Center Heelkunde LUMC
Postzone K-6-R, Postbus 9600
Leiden 2300 RC
The Netherlands
071 526 3500
ClinicalResearchCenter@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Low-risk invasive breast cancer: tumour < 1 cm, grade 1-2 or tumour 1-2 cm, grade 1
2. Registration within 3 months after Breast Conserving Surgery
3. R0 resection
4. HER2 negative
5. pN0 or pN0(itc) disease
6. ER positive > 50%
7. Age ≥70 years
8. Indication for standard radiotherapy
9. Willing to complete quality of life questionnaires and geriatric assessments
10. Female
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Indication for hormonal therapy
2. Bilateral
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5983 |
| NTR-old | NTR6147 |
| CCMO | NL58117.058.16 |
| OMON | NL-OMON53002 |