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New treatment option for Oligometastatic Disease
Official title Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease
ClinicalTrials.gov ID: NCT06356779
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Pregnancy
- Diffuse cancer disease, which cannot be locally ablated, i.e., leptomeningeal carcinomatosis, malignant pleural effusions, lymphangitic...
- If LAT is deemed unsafe by the MDT (e.g., tumor perforation of hollow organs) In addition, the patients receiving SBRT to oligometastatic sites...
- 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...
- If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints according to Appendix...
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Capital Region of Denmark, Denmark
- Herlev, Capital Region of Denmark, Denmark
- Hillerød, Capital Region of Denmark, Denmark
- Aarhus, Central Jutland, Denmark
- Herning, Central Jutland, Denmark
- Aarhus, Central Region Denmark, Denmark
- Aalborg, Northern Region of Denmark, Denmark
- Roskilde, Region Sjælland, Denmark
- Odense, Southern Denmark Region, Denmark
- Sønderborg, Southern Denmark Region, Denmark
- Vejle, Southern Denmark Region, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Capital Region of Denmark, Denmark; Herlev, Capital Region of Denmark, Denmark; Hillerød, Capital Region of Denmark, Denmark; Aarhus, Central Jutland, Denmark; Herning, Central Jutland, Denmark; Aarhus, Central Region Denmark, Denmark and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.