English: Stereotactic, Radiotherapy, Lung, Metastases, Oligometastases, CyberKnife. Dutch: Stereotactische, Radiotherapie, Long, Uitzaaiingen, Oligometastasen, CyberKnife.
Conditions
Interventions
Patients are treated with 1-7 fractions of stereotactic radiotherapy using the CyberKnife. The treatment schedule will depend on the tumor location and size.
1. Peripheral tumors >3cm: 3 fractions o
Sponsors
The individuals responsible for initiating and managing the study and who are responsible for ensuring that the trial is properly registered are Dr. J.J.Nuyttens and Prof.Dr. P.C. Levendag.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Minimal life expectancy of 6 months; 2. WHO 0-3; 3. Metastatic disease limited to a maximum of 2 organs; 4. No more than 5 metastatic lesions and a controlled primary tumor site; 5. Diagnostic imaging includes at least a PET-scan and CT ¨Cthorax/abdomen, of which one is not older than 4 weeks at the time of referral for SBRT; 6. Primary tumor must be treated at least 4 months before the diagnosis of the metastasis; 7. Patients are discussed in a multidisciplinary team, including a pulmonologist and/or medical oncologist; 8. Patients with more than 2 lung metastases should be treated with a first line chemotherapeutical agent prior to stereotactic radiotherapy in all cases unless the patient is not suitable for chemotherapy; 9. Patients must be 18 years or older; 10. Woman with pregnancy potential must use an effective contraceptive method; 11. Patients must sign a study-specific consent form; 12. FEV1 > 40% of predicted; 13. Leukocytes > 3 x 109; 14. Thrombocytes > 100 x 109; 15. Bilirubine 60%.
Exclusion criteria
Exclusion criteria: 1. Pregnant women; 2. Inability to lie flat for at least 90 minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local tumor control rate at 1 year. Sample size was calculated with P0=70%, P1=90%, and alpha/beta =0.10. 1. P0= largest probability of Local Tumor Control that implies that therapeutic activity is too low and does not warrant further investigation; 2. P1= smallest probability of Local Tumor Control that implies that therapeutic activity is sufficient to warrant further investigation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall surival (at one and two years); 2. Progression-free survival (at one and two years); 3. Treatment related toxicity (acute at 6 months; Late at 2 years). | — |
Contacts
Public ContactN.C. Voort van Zyp, van der
Outcome results
None listed