Long-term assessment of local therapy for oligometastatic disease
A National Longitudinal Study of Metastases-directed Local Ablative Therapy for Patients With Oligometastatic Disease - a Combined Interventional and Observational Trial
This study is testing different local treatments for people with oligometastatic cancer to see how well they work over time and to help choose the best options for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 11 sites (Copenhagen, Capital Region of Denmark and 10 other locations) |
| Trial ID | NCT06356779 on ClinicalTrials.gov |
What this trial studies
This national multicenter observational and interventional study evaluates the disease trajectory of patients with oligometastatic disease (OMD) receiving local metastasis-directed therapy. It includes various treatment modalities such as surgical metastasectomy, radiotherapy, thermal ablation, and electroporation for patients with any non-hematological cancer. The study aims to assess the effectiveness of these therapies over time and create a prediction model for patient selection. Both observational and interventional cohorts will be included to gather comprehensive data on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with stage IV non-hematological cancer who have oligometastatic disease and are eligible for local ablative therapy.
Not a fit: Patients with hematological cancers or those with more than five oligometastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with oligometastatic disease, potentially leading to better outcomes and prolonged survival.
How similar studies have performed: Other studies have shown promise with similar approaches, but this study aims to provide a more comprehensive evaluation across multiple treatment modalities.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histology or cytology proven non-haematological cancer * Stage IV disease * ECOG performance status ≤ 2 * Life expectancy \> 6 months * A baseline scan within 42 days of inclusion (PET-CT or CT or MRI scan) is required, preferably within 28 days for optimal prospective evaluation * Primary tumor must be controlled, defined by the radiographical response of the primary tumor by systemic or local treatment. If progressing, it is planned to be treated with local ablative therapy (LAT) * Oligometastatic disease according to the ESTRO-EORTC classification, both de-novo and induced, including oligoprogression * A maximum of five oligometastases or oligopersistent/oligoprogressive lesions. More than five metastases are allowed in the following cases, 1) location in a defined anatomical entity or 2) location in immediate proximity and as such, cannot be treated separately * All oligometastatic lesions must be planned for definitive LAT. If all visible/progressive/persistent disease is not treated, the patient cannot be included * Local ablative therapy must be deemed clinically relevant for the individual patient by the treating team of physicians, or a multidisciplinary team and discussion must be documented in the patient chart * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * 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) In addition, the patients receiving SBRT to oligometastatic sites should comply with the following criteria. * 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 * If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints according to Appendix 2 - Radiotherapy Recommendations
Where this trial is running
Copenhagen, Capital Region of Denmark and 10 other locations
- Copenhagen University Hospital Rigshospitalet — Copenhagen, Capital Region of Denmark, Denmark (Not_yet_recruiting)
- Copenhagen University Hospital Herlev and Gentofte — Herlev, Capital Region of Denmark, Denmark (Recruiting)
- Hillerød Hospital — Hillerød, Capital Region of Denmark, Denmark (Not_yet_recruiting)
- Aarhus University Hospital — Aarhus, Central Jutland, Denmark (Not_yet_recruiting)
- Gødstrup Hospital — Herning, Central Jutland, Denmark (Not_yet_recruiting)
- Danish Center for Particle Therapy — Aarhus, Central Region Denmark, Denmark (Not_yet_recruiting)
- Aalborg University Hospital — Aalborg, Northern Region of Denmark, Denmark (Not_yet_recruiting)
- Zealand University Hospital, Roskilde and Næstved — Roskilde, Region Sjælland, Denmark (Not_yet_recruiting)
- Odense University Hospital — Odense, Southern Denmark Region, Denmark (Not_yet_recruiting)
- Sønderborg Hospital — Sønderborg, Southern Denmark Region, Denmark (Not_yet_recruiting)
- Vejle Hospital — Vejle, Southern Denmark Region, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Michael RT Laursen, MD — Copenhagen University Hospital Herlev and Gentofte
- Study coordinator: Michael RT Laursen, MD
- Email: michael.ruben.teindl.laursen@regionh.dk
- Phone: +45 3868 9202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.