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Breast conserving therapy using Accelerated Partial Breast Irradiation (APBI) in elderly patients: a feasibility study

Breast conserving therapy using Accelerated Partial Breast Irradiation (APBI) in elderly patients: a feasibility study - Breast conserving therapy using APBI in elderly patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45136
Enrollment
509
Registered
2010-08-01
Start date
2011-01-24
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Breast cancer mammacarcinoom

Interventions

None listed

Sponsors

Haaglanden Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histological confirmed breast cancer (DCIS and invasive) ductal subtypes T1-2 smaller than 30mm as determined by ultrasound N0 on palpation and ultrasound examination Unicentric, Unifocal disease (radiological), multifocal when limited within 2 cm of the index lesion) Age * 60 Any hormonal receptor status, hormonal therapy allowed following Dutch treatment guidelines Technically eligible for lumpectomy or radiotherapy No contra indications for lumpectomy and sentinal node procedure Written informed consent Willing to fill out the QOL, geriatric- and co morbidity questionaires - if applicable

Exclusion criteria

Exclusion criteria: Patients not eligible / fit for lumpectomy and sentinal node procedure pT2 (>30mm), pT3 and pT4 Positive surgical margins Multi centricity; multifocal (> 2cm from the index lesion) Extensive intraductal carcinoma; lympho-vascular invasion Previous treatment of ipsilateral breast tumor (DCIS or invasive) Paget disease of the nipple Cutaneous involvement Distant metastases; > pN1a Previous radiotherapy on the ipsilateral breast neo adjuvant chemotherapy for current malignancy Collagen diseases (systematic erythematosus lupus, scleroderma, dermatomyositis) Psychiatric diseases or other that prevents signing of informed consent Other neoplasm's in the last 5 year with exception of skin tumors (excl melanoma) and intraepthelial lesions of the cervix uteri

Design outcomes

Primary

MeasureTime frame
Confirm favorable tumor control and cosmetic outcome (2 toxicity, 90% good/excellent cosmetic result).

Secondary

MeasureTime frame
Gathering QOL, geriatric and other information for modeling patient outcome. EORTC QOL C30/ breast module, ACE 27, registration multi-pharmacy, geriatric screening questionnaire (incl. GFI ,G8 and VES 13). Also digital pictures will be made after 3 and 5 years for objective cosmetic results.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)