Trial Title:
Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease
NCT ID:
NCT06356779
Condition:
Oligometastatic Disease
Metastases
Ablation Techniques
Radiotherapy
Stereotactic Radiation
Surgery
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
oligometastatic disease
metastases-directed therapy
metastasectomy
thermal ablation
stereotactic ablative radiotherapy
stereotactic radiosurgery
endpoints
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Local ablative therapy (LAT)
Description:
Surgical metastasectomy, stereotactic ablative radiotherapy, thermal ablation, or
electroporation to all oligometastatic lesions
Arm group label:
Local ablative therapy
Other name:
Metastases-directed therapy
Summary:
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.
Detailed description:
Patients with oligometastatic disease (OMD) are often treated with a combination of
surgery, stereotactic radiotherapy, thermal ablations, or electroporation, either
concurrently or in succession, however, most studies are focused on a single modality. In
addition, local differences in the use of local ablative therapy (LAT) in different
metastatic sites and diseases exist and may impact outcomes for patients with OMD.
OLIGO-DK is designed to address these shortcomings. The aim is to offer LAT with any
modality to all patients with OMD from all primary cancer histologies and in all
metastatic sites, where it is deemed clinically relevant, within the framework of a
national prospective multicenter study, combining both standard and non-standard LAT of
OMD in an observational and an interventional cohort, respectively. At the same time, we
aim to assess the longitudinal treatment trajectory of oligometastatic patients and
create a national network for radiotherapy of oligometastases. Finally, we aim to create
a clinically applicable prediction model for patient selection.
The trial is a national, prospective, multicentre trial. Patients with both genuine and
induced non-hematological OMD who are receiving metastases-directed local ablative
therapy are included, and all LAT modalities of all metastatic sites from all primary
cancers are included. The trial will include both an observational cohort and an
interventional cohort.
The observational cohort will include patients with OMD who are treated with LAT, which
is considered standard-of-care according to national guidelines. The interventional
cohort will include patients who are treated with implemented LAT techniques but for
indications that are not considered standard-of-care. The final decision on treatment
choice is made by the treating physician in consultation with the patient, and the
patient may be referred across regional borders for specific treatments. This trial is
not on its own designed for the evaluation of novel or experimental LAT techniques, where
safety is a primary concern. In these cases, a separate ethical approval protocol is
necessary. Patients can still be included in the OLIGO-DK protocol for prospective data
collection. In addition, inclusion in this protocol does not impede patients from
inclusion in other oligometastatic protocols. Patients are prospectively included,
followed, and evaluated by the Centralised Trial Unit and remain included for follow-up
until death or patient preference. Due to the nature of oligometastatic disease, patients
may receive LAT more than once in the protocol, if the disease is amenable to further
local ablative therapy.
The trial will initiate accrual in the Capital Region of Denmark, with subsequent
expansion after the first interim analysis. A national OMD MDT conference and a
nationwide overview of LAT options will be established during the trial. All departments
of oncology, and their associated departments of surgery and interventional radiology
performing LAT will be able to include patients.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Copenhagen University Hospital Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Mette Pøhl, MD PhD
Investigator:
Last name:
Mette Pøhl, MD PhD
Email:
Principal Investigator
Investigator:
Last name:
Maja Maraldo, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Morten Suppli, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Rene H Petersen, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Hans-Christian Pommergaard, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Søren Møller, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Michael Achiam, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Mikkel Rosendahl, MD PhD
Email:
Sub-Investigator
Facility:
Name:
Copenhagen University Hospital Herlev and Gentofte
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Michael RT Laursen, MD
Phone:
+453868 9202
Email:
michael.ruben.teindl.laursen@regionh.dk
Investigator:
Last name:
Mette Felter, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Henriette Lindberg, MD PhD
Email:
Principal Investigator
Investigator:
Last name:
Eva Serup-Hansen, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Sebastian Krog, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jesper Palshof, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Bodil Engelmann, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Eva Ellebæk, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Lisbet Hölmich, MD PhD
Email:
Sub-Investigator
Facility:
Name:
Hillerød Hospital
Address:
City:
Hillerød
Zip:
3400
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Maria Lendorf
Investigator:
Last name:
Maria Lendorf, MD PD
Email:
Principal Investigator
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Mette Marie Fode, MD PhD
Email:
mettfode@rm.dk
Investigator:
Last name:
Mette Marie Fode, MD PhD
Email:
Principal Investigator
Investigator:
Last name:
Azza Khalil, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Thomas Decker Christensen, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Ole Graumann, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jørgen Bjerggaard Jensen, MD PhD
Email:
Sub-Investigator
Facility:
Name:
Gødstrup Hospital
Address:
City:
Herning
Zip:
7400
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Trine Øllegaard
Investigator:
Last name:
Trine Øllegaard, MD PhD
Email:
Principal Investigator
Facility:
Name:
Danish Center for Particle Therapy
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Britte Weber, MD PhD
Investigator:
Last name:
Britta Weber, MD PhD
Email:
Principal Investigator
Facility:
Name:
Aalborg University Hospital
Address:
City:
Aalborg
Zip:
9000
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Jimmy Søndergaard, MD PhD
Contact backup:
Last name:
Laurids Ø Poulsen, MD PhD
Investigator:
Last name:
Jimmi Søndergaard, MD PhD
Email:
Principal Investigator
Investigator:
Last name:
Laurids Ø Poulsen, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Hella Sand, MSc
Email:
Sub-Investigator
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Tine Schytte, MD PhD
Investigator:
Last name:
Tine Schytte, MD PhD
Email:
Principal Investigator
Investigator:
Last name:
Jørgen Johansen, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Christina Nyborg, MD PhD
Email:
Sub-Investigator
Facility:
Name:
Sønderborg Hospital
Address:
City:
Sønderborg
Zip:
6400
Country:
Denmark
Status:
Not yet recruiting
Facility:
Name:
Vejle Hospital
Address:
City:
Vejle
Zip:
7100
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Charlotte Kristiansen, MD
Investigator:
Last name:
Charlotte Kristiansen, MD
Email:
Principal Investigator
Investigator:
Last name:
Lars Fokdal, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Lise Bentzen, MD PhD
Email:
Sub-Investigator
Facility:
Name:
Zealand University Hospital, Roskilde and Næstved
Address:
City:
Roskilde
Zip:
4000
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Julie Gehl, MD DMSc
Investigator:
Last name:
Julie Gehl, MD DMSc
Email:
Principal Investigator
Start date:
April 15, 2024
Completion date:
December 31, 2035
Lead sponsor:
Agency:
Gitte Fredberg Persson MD PhD
Agency class:
Other
Source:
Herlev Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06356779
