Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGitte Fredberg Persson MD PhD

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Local ablative therapy (LAT)

    Procedure/Surgery

    Surgical metastasectomy, stereotactic ablative radiotherapy, thermal ablation, or electroporation to all oligometastatic lesions

Treatment groups

1,200 Participants
are divided into 1 treatment group
Group A: Local ablative therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Assessed every 3-6 months for 5 years or life-long

Secondary outcomes

1

Progression-free survival

Defined as time from first day of LAT to disease progression at any site or death

Time frame
Assessed every 3-6 months for 5 years or life-long
2

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

Time frame
Assessed every 3-6 months for 5 years or life-long
3

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

Time frame
Assessed every 3-6 months for 5 years or life-long
4

Overall survival

Defined as time from first day of first LAT to death from any cause

Time frame
Assessed every 3-6 months for 5 years or life-long

Other outcomes

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