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van CCT (UK)

van CCT (UK)

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

- candidate number9702
- NTR NumberNTR2931
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jun-2011
- Secondary IDs10-042 METC ZuidwestHolland
- Public TitleBreast conserving surgery using Accelerated Partial Breast Irradiation in Elderly Patients with breast cancer.
- Scientific TitleBreast conserving therapy using APBI in Elderly Patients: A feasibility study.
- hypothesisLocal control and toxicity in breast conserving therapy using APBI is not inferior to classical 50 Gy irradiation.
- Healt Condition(s) or Problem(s) studiedEarly stage breast cancer , Elderly female patients
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 24-jan-2011
- planned closingdate1-jan-2014
- Target number of participants710
- InterventionsDepending 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).
- Primary outcomeLoco regional tumor control at 5 years.
- Secondary outcome1. (Loco regional) tumor control;
2. Side effects;
3. (Inter current) death;
4. Geriatric condition (questionnaires);
5. Co-morbidity and usage of medication.
- Timepoints1. Before surgery;
2. 3, 6 and 12 months after surgery;
3. Yearly until death.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Radiotherapiecentrum West
- Funding
(Source(s) of Monetary or Material Support)
Zorgvernieuwingsgelden, MC Haaglanden, Radiotherapiecentrum West
- PublicationsIntraoperative radiotherapy during breast conserving surgery; a study on 1822 cases treated with electrons. Veronesi et al, B4reast Cancer Res Treat. 2010 Nov;124(1):141-51. Epub 2010 Aug 15. PMID: 20711810
- Brief summaryThe treatment policy for elderly patients with early stage breast cancer is largely intuitive and is just partly based on evidence as these patients are often not included in phase II/III studies. As a consequence a relative large proportion is treated by breast ablation and sentinel node biopsy. Accelerated partial breast irradiation (APBI) either by intra-operative or external beam radiotherapy might be a good alternative for elderly patients offering less treatment burden in a shortened treatment time and a limited chance of recurrence. International studies using APBI claim equivalent tumor control and cosmetic results compared to conventional fractionated radiotherapy.
The elderly patient is a complex patient due to the age, the (geriatric) condition with frequent co-morbidity and usage of multiple medications. The collection of information of these (geriatric) conditions in Dutch radiotherapy centers will give us a solid base to construct algorithms to predict patient outcome (tumor related, morbidity and intercurrent disease).
- Main changes (audit trail)The first amendment of this trial recalculated the sample size. The original sample size calculation kept in consideration that 25% of the included patients would die of old age within a 5 year period. Based on the characteristics of the patients included during the first two years of this trial, it was justified to abandon this consideration. New sample size according to the first amendment is 179 patients per treatment arm. Also included in the first amendment were some minor changes in the in- and exclusion criteria. The most important were: exclusion is limited to neoadjuvant chemotherapy (to prevent bias between both treatment arms) and patients that were treated for contralateral breast cancer more than five years ago are no longer excluded. The second amendment of this trial extends the cosmetic evaluation with objective analysis through digital photography, including whole breast irradiated control groups.
- RECORD9-jun-2011 - 2-feb-2014

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