C25
Conditions
Interventions
Group 1: iort 1x10-20 Gy
Sponsors
Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Before registration, patient's written informed consent has been obtained 2. Age = 18 years, male and female patients 3. Legal capacity, patient is able to understand the nature, significance, and consequences of the study 4. Surgical and medical operability 5. WHO performance status = 2
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy to the region(s) to be treated 2. Chemotherapy and/or targeted treatment within 2 weeks before the start of SBRT 3. Presence of infiltration of OARs such as tracheal, oesophageal infiltration or infiltration of small/large bowel or stomach 4. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The documentation of the delivered dose during IORT | — |
Secondary
| Measure | Time frame |
|---|---|
| Definition of a QA procedure, which should also be applied in a multi-centre study. Acute and late toxicity (=90 days after RT is acute; late >90 days) measured as NCI-CTCAE v4.0 for adverse event reporting. Overall Survival Recurrence-free survival Patterns of local and distant recurrence Postoperative complications. | — |
Countries
Germany
Contacts
Public ContactEleni Gkika
Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Outcome results
None listed