Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Fibrosis
- Lymphedema
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time...
The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time in general is shortened 5 days. Thus the dose levels for boost patients are: 63 Gy / 51.52 Gy / 28 fractions, 57 Gy / 50 Gy / 25 fractions, 52.2 Gy / 42.3 Gy / 18 fractions, and 45.75 Gy / 40 Gy / 15 fractions. The primary endpoint is arm lymphedema 3 years after radiation therapy, but other late radiation morbidities will also be evaluated along with recurrence and sites of recurrence. Follow up of morbidity will continue for 10 years. The hypothesis is that women operated for early breast cancer with indication for loco-regional radiation therapy can be offered moderately hypofractionated therapy without developing more late radiation induced morbidity compared to normofractionated radiation therapy.
Tracking Information
- NCT #
- NCT02384733
- Collaborators
- Danish Cancer Society
- Investigators
- Study Chair: Lars Stenbygaard, MD Aalborg University Hospital Study Chair: Troels Bechmann, MD,PhD Vejle Hospital Study Chair: Mette Nielsen, MD Odense University Hospital Principal Investigator: Birgitte Offersen, MD Aarhus University Hospital Study Chair: Hanne Nielsen, MD Aarhus University Hospital Study Chair: Claus Kamby, MD Rigshospitalet, Denmark Study Chair: Sami Al-Rawi, MD Naestved Hospital Study Chair: Mechthild Krause, MD Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie Study Chair: Andreas Schreiber, MD Praxis für Strahlentherapie, Dresden Study Chair: Ingvil Mjaaland, MD Stavanger Hospital Study Chair: Tanja Marinko, MD Institute of Oncology Ljubljana Study Chair: Carine Kirkove, MD Radiotherapy Department Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels Study Chair: Egil Blix, MD University Hospital of North Norway, Tromsoe Study Chair: Unn-Miriam Kasti Kristiansand Hospital, Norway
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