Rationale: SABR (Stereotactic ablative radiotherapy) is one of the standard treatment options besides surgical resection for limited lung metastases (oligometastases) from colorectal cancer. High efficacy in terms of local control of metastatic lesions treated has been shown. Nevertheless, the precise effect of SABR upon progression-free- and overall survival in these patients is unknown. To further evaluate and develop local treatment options in metastatic disease, more information is necessary regarding the impact upon - and the pattern of - disease progression of local treatment options such as SABR. Objective: To determine the effect upon progression free survival and upon tumorload relative to baseline, both at one year after randomisation of immediate SABR versus delayed SABR (a scan-and-personalise policy). Secondarily, patterns of progression, patient-reported symptoms and quality of life will be monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
University Medical Center Groningen
Groningen, Netherlands
Progression free survival (PFS)
Time frame: 12 months after randomisation
Relative change of tumourload expressed as volume of all tumour at one year divided by volume of all tumour at time of randomisation;
Time frame: 12 months after randomisation
Time to failure of local strategy (TFLS): failure = death or progressive disease NOT amenable to local treatment
Time frame: when it occurs
Progression of target lesions as measured by CT
Time frame: 12 months after randomisation
Health-related quality of life profile
Euro-Qol 5 dimensions (EuroQoL-5D); Hospital Anxiety and Depression Scale (HADS); European Organization for Research and Treatment of Cancer quality of life questionnaire - lung cancer module (EORTC-QLQ-LC13)
Time frame: Baseline; 3 months after randomisation and at 6, 9, 12, 15, 18, 21 and 24 months
Progression of lesions other than target lesions as measured by CT
Time frame: 12 months after randomisation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.