Breast conserving surgery using Accelerated Partial Breast Irradiation in Elderly Patients with breast cancer.

Breast conserving therapy using APBI in Elderly Patients: A feasibility study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26007

Enrollment

710

Registered

2011-06-09

Start date

2011-01-24

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early stage breast cancer in elderly female patients. age >=60 year T1/2 N0 M0 Oudere vrouwen met borstkanker in een vroeg stadium leeftijd >= 60 jaar

Interventions

Depending on the facilities of the centre either: 1. Intra-operative radiotherapy at lumpectomy (21 Gy 90% isodose, “ELIOT procedure”)

2. Postoperative external beam radiotherapy (3DCRT or IMRT, 10x3,4 Gy ICRU, 10 fractions in 2 weeks).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological confirmed breast cancer (DCIS and invasive) subtypes; 2. T1 as determined by ultrasound; 3. T2 smaller than 30 mm as determined by ultrasound, ER/PR + Herneu --, + or ++; 3. N0 on palpation / ultrasound examination; pN1mi, pN1a (by axill.lymphnode dissection) Unicentric, Unifocal disease (radiological), multifocal when limited within 2 cm; 4. Age 60 or older; 5. Any hormonal receptor status, hormonal therapy allowed cf Dutch treatment guidelines; 6. Technically eligible for lumpectomy or radiotherapy; 7. No contra indications for lumpectomy and sentinel node procedure; 8. Written informed consent; 9. Willing to fill out the QOL, geriatric Q and comorbidity questionnaires.

Exclusion criteria

Exclusion criteria: 1. Patients not eligible / fit for lumpectomy and sentinel node procedure; 2. T2 smaller than 30 mm and triple negative or Her2neu +++; 3. pT2(>30 mm), pT3 and pT4; 4. Positive surgical margins; 5. Multi centricity; multifocal (> 2cm from the index lesion); 6. Extensive intraductal carcinoma; lympho-vascular invasion; 7. Previous treatment of ipsilateral breast tumor (DCIS or invasive); 8. Paget disease of the nipple; 9. Distant metastases; > pN2a (4 or more positive axillary lymphnodes); 10. Previous radiotherapy on the thoracic region; 11. (Neo adjuvant) chemotherapy or other Cytotoxic medication; 12. Collagen diseases (systemic erythematosus lupus, scleroderma, dermatomyositis); 13. Psychiatric diseases or other that prevents signing of informed consent; 14. Other neoplasm’s in the last 5 year with exception of skin tumors (excl melanoma) and intraepithelial lesions of the cervix uteri.

Design outcomes

Primary

Measure	Time frame
Loco regional tumor control at 5 years.	—

Secondary

Measure	Time frame
1. (Loco regional) tumor control; 2. Side effects; 3. (Inter current) death; 4. Geriatric condition (questionnaires); 5. Co-morbidity and usage of medication.	—

Contacts

Public ContactU.J. Fisscher

PO box 432

fisurs@mchaaglanden.nl+31 (0)70 3302013

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)