Pre-operative accelerated partial breast radiotherapy will be superior compared to conventional radiotherapy for fibrosis and cosmetic outcome, and we think this new treatment will be superior to conventional post-operative whole breast radiotherapy…
ID
Bron
Verkorte titel
Aandoening
breast cancer, partial breast radiotherapy, pre-operative
borstkanker, partiele borst bestraling, pre-operatief
Ondersteuning
Plesmanlaan 121
1066 CX Amsterdam
Amsterdam, the Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Tumor response after radiotherapy will histologically be evaluated. Local control will be evaluated during follow-up.
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Cosmetic evaluation will take place including digital photographs which will be analyze using computer software as well as questionnaires for the patient and treating physician.
Achtergrond van het onderzoek
Patients with early stage breast cancer are treated with a combination of surgery, radiotherapy and often with systemic therapy. Radiotherapy is part of breast conserving therapy and is known to reduce LR rates in all patients with 60-70% although the absolute benefit differs in different subgroups. So far, no patient groups can be defined in whom radiotherapy would not be necessary. It is estimated that in approximately half of the patients whole breast radiotherapy is not necessary, while in others the tumor might be resistant to radiotherapy. It is likely that tumor cells differ in their response to radiotherapy and thus influence the LR rate after BCT. If it would be possible to predict tumor response to radiotherapy, a more tailored treatment can be advised to individual patients (higher boost dose or primary mastectomy).
Doel van het onderzoek
Pre-operative accelerated partial breast radiotherapy will be superior compared to conventional radiotherapy for fibrosis and cosmetic outcome, and we think this new treatment will be superior to conventional post-operative whole breast radiotherapy which is used up till now.
Onderzoeksopzet
1. 60 Patients will be studied as a test set to identify predictive profiles;
2. 60 patients will be used as a validation set.
Onderzoeksproduct en/of interventie
The additional procedures in this study are:
1. Biopsies before radiotherapy;
2. Cytology at day 2 and 12 of radiotherapy;
3. MRI before operation;
4. A Pet scan will be done twice;
5. Also, the sentinel procedure will take place before radiotherapy.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients ≥ 60 years of age with proven adenocarcinoma of the breast presenting with an unifocal lesion on mammogram and MRI (no diffuse microcalcifications), tumor size up till 3.0 cm.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age < 60 year;
2. Multifocal disease;
3. Lobulair carcinoom;
4. pN+.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL2515 |
NTR-old | NTR2633 |
Ander register | NKI : M08PBI |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |