C33 C34 C22 C25 C74 C77 C76 C79
Conditions
Interventions
Group 1: SBRT using a Simultaneous Integrated Protection (SIP)-IMRT technique allowing commonly employed doses to the dominant PTV (PTVdom) either as 5 fractions x 10 Gy or as 8 fractions x 7.5 Gy or
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. Diagnosis of cancer, confirmed by either histology, cytology, or clinically (imaging and tumour markers); 5. Tumour located close to highly vulnerable organs at risk (OAR): (1) precluding SBRT at doses to a biologically equivalent dose (BED) of <80 Gy (aß10) prescribed to the Planning target volume (PTV)according to ICRU with standard planning; (2) due to violation of dose constraints for OAR as specified in Table 2 (see Appendices); 6. Tumour location between the plane of the cranial tips of the lungs and the inferior border of the pelvis. All lesions need to be treatable by local curative therapy; 7. 1-3 lesions with at least 1 lesion requiring SIP-IMRT; all diagnosed lesions are treated with a local treatment method; combinations of SBRT and surgery or other local therapies are allowed; 8. WHO performance status = 2; 9. Life expectance = 6 months; 10. Patients of childbearing / reproductive potential should use adequate birth control measures, during the study treatment period. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly; 11. For metachronous lesions patients cannot be registered in this study more than once.
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 |
|---|---|
| Acute (up to 90 days) and late toxicity (project duration: 24 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (RECIST, PERCIST), Local control rates, Progression-free survival, Overall Survival | — |
Countries
Germany
Contacts
Public ContactEleni Gkika
Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Outcome results
None listed