metastases
Conditions
Interventions
Randomisation (1:1) between SABR to remaining metastases after chemotherapy
versus observation.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients above age 18. - WHO-PS (performance status) 0 - 1. - Patients with unresectable metastases to lung, and/or liver, and/or one adrenal gland, who have received systemic therapy and show partial remission or stable disease. - Using RECIST 1.1 criteria (see the Appendix): Partial response or stable disease at restaging (compared with staging prior to last 4*6 cycles of chemotherapy). Note this exception: After bevacizumab-containing treatment, response of liver metastases should be assessed using CT-morphologic criteria as described by Chun et al., JAMA 2009;302:2338 - Possibility to define target lesions that fulfil the following criteria: - No lesion larger than 4 cm; - Not more than 5 metastases >= 8 mm in total (lesions smaller than 8 mm in diameter are NOT counted and will NOT be irradiated); - Not more than 3 lesions >= 8 mm in the lung; - Not more than 3 lesions >= 8 mm in the liver; - If adrenal gland metastasis: only unilateral lesion; - primary tumour has been completely removed
Exclusion criteria
Exclusion criteria: Not fulfilling the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: Rate of progression free survival at one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: Local progression free survival; location of progression: irradiated target lesion / non-irradiated target lesion / both; rate of progression outside target lesions; time to failure of local strategy; relative change of tumour load at one year; rate of metastases in organs primarily unaffected; health-related quality of life and patient-rated specific symptoms; overall survival; same as primary and secondary endpoints assessed at two, three, and five years. | — |
Countries
Netherlands
Outcome results
None listed