Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Paracelsus Medical University
With
Study population: See Points 4.1 und 4.2 Inclusion/Exclusion criteria of the entire protocol Operation: * Lumpectomy / segmentectomy / tumorectomy with sufficient safety margins (see above). Lymph node assessment must follow a sentinel node concept. * Perioperative antibiotic prophylaxis is mandatory * After IORT, radio-opaque clips have to be fixed at the tumor bed. Histology: R0-Resection is mandatory Chemotherapy: neoadjuvant:allowed adjuvant: allowed. There are no limitations towards special chemotherapeutic schemes and schedules. Radiotherapy: IOERT * IOERT is performed on mobile or fixed linacs * Reference dose: 11 Gy specified as maximum dose, with a minimum target volume dose of 90% encompassing the PTV (i.e. 10 Gy). WBRT * must start within day 36- 56 postoperatively (week 6 - 8 p.o.) in case of adjuvant hormonal treatment (or no further tumor specific medication) * In case of adjuvant chemotherapy, a time - gap between IOERT and WBRT up to 9 months is allowed. * Single reference dose per fraction: 2,7 Gy (ICRU) * Number of fractions: 15, Number of fractions per week: 5 * Total WBRT dose: 40,5 Gy RT of regional lymphatics: exclusion criterion Diagnostics of Local recurrence: * yearly mammographies, * optional breast sonography, MRI * LR has to be histologically confirmed Follow-up screening for detection of metastases (minimum requirements): * Chest X-Ray, optional * abdominal sonography, optional * lab tests incl. tumor markers, optional Assessment of acute toxicity of WBRT according to CTC-toxicity Scoring-systems: Assessment of late toxicity according to LENT-SOMA scoring-systems Assessment of cosmetic outcome according to 5-point- Scoring System (vanLimbergen) starting before WBRT, including photo documentation in standardized positions
Age
35–any
Sex
FEMALE
Healthy volunteers
Not accepted
