About this trial
This prospective national multicenter observational and interventional study aims to assess the longitudinal disease trajectory of patients with oligometastatic disease (OMD) who receive local metastasis-directed therapy. Patients with any category of OMD from any non-hematological cancer are eligible for inclusion. Local ablative therapy (LAT) includes surgical metastasectomy, radiotherapy, thermal ablation, and electroporations.
The primary objective is to assess the time to failure of LAT strategy in patients with OMD from any primary cancer treated with all LAT modalities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histology or cytology proven non-haematological cancer
Stage IV disease
ECOG performance status ≤ 2
Life expectancy > 6 months
Disqualifiers
Pregnancy
Diffuse cancer disease, which cannot be locally ablated, i.e., leptomeningeal carcinomatosis, malignant pleural effusions, lymphangitic carcinomatosis, or peritoneal carcinomatosis
If LAT is deemed unsafe by the MDT (e.g., tumor perforation of hollow organs)
The size of the target is limited by the ability to safely deliver locally ablative doses to the metastatic lesions. Generally, an upper limit of 5 cm is recommended
Trial design
Single group
Treatments tested in this trial
Local ablative therapy (LAT)
Procedure/SurgerySurgical metastasectomy, stereotactic ablative radiotherapy, thermal ablation, or electroporation to all oligometastatic lesions
Treatment groups
Trial outcomes
Primary outcomes
Time to failure of local ablative therapy (LAT) strategy
Defined as time from first day of LAT to progression of disease, locally or metastatically, not amenable to new LAT or progression of disease leading to initiation of or change in systemic treatment
Secondary outcomes
Progression-free survival
Defined as time from first day of LAT to disease progression at any site or death
Time to widespread progression
Defined as time from first day of LAT to disease progression not amenable to new LAT. Deaths from any cause are censored. Initiation of or change in systemic treatment is ignored
Freedom from systemic treatment
Defined as time from first day of LAT to initiation of systemic treatment, change in systemic treatment, or end of systemic treatment due to progression. Change in or end of systemic treatment due to toxicity is ignored
Overall survival
Defined as time from first day of first LAT to death from any cause
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gitte Fredberg Persson MD PhD
Lead sponsor
Herlev Hospital
Sponsor institution