JOURNAL ONKOLOGIE – STUDIE
Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy
Rekrutierend
NCT-Nummer:
NCT04535895
Studienbeginn:
November 2020
Letztes Update:
13.11.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Breast Neoplasms
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Medical University of Graz
Collaborator:
-
Studienleiter
Principal Investigator
Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
Kontakt
Kontakt:
Phone: 0043 316 385 87869
E-Mail: tanja.langsenlehner@medunigraz.at» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Medical University of Graz
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Tanja Langsenlehner, MD» Ansprechpartner anzeigen
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Tanja Langsenlehner, MD» Ansprechpartner anzeigen
Studien-Informationen
Brief Summary:Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local
control and overall survival. Dose escalation of the tumor bed by addition of a boost after
whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer.
Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal
treatment plans than conventional sequential boost, in addition, SIB enables a reduction in
the overall treatment time by 1 week compared to conventional boost techniques.
The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with
breast-conserving surgery in combination with radiotherapy using SIB technique.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Invasive breast cancer or ductal carcinoma in situ
- Breast conserving surgery
- Complete tumor resection
- Treatment with adjuvant radiotherapy of the breast
- Indication for boost Irradiation
- Given informed consent
Exclusion Criteria:
- Incomplete tumor resection
- Mastectomy
- Distant metastases at diagnosis
- Unable to give informed consent
Studien-Rationale
Primary outcome:1. Acute Radiation induced toxicity (grade 2 or higher) (Time Frame - Measurement at the last 1 day of radiotherapy):
Toxicity score using Common Terminology for Adverse Events (CTCAE)
2. Acute Radiation induced toxicity (grade 2 or higher) (Time Frame - Measurement 3 months after completion of radiotherapy):
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Geprüfte Regime
- Simultaneous integrated boost:
Adjuvant breast cancer irradiation including simultaneous integrated boost
Quelle: ClinicalTrials.gov