## Protocol Section
### Identification Module
**NCT ID:** NCT06356779

**Acronym:** OLIGO-DK

**Brief Title:** Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease

**Official Title:** A National Longitudinal Study of Metastases-directed Local Ablative Therapy for Patients With Oligometastatic Disease - a Combined Interventional and Observational Trial

#### Organization Study ID Info
**ID:** H-23066725
#### Organization
**Class:** OTHER
**Full Name:** Herlev Hospital
### Status Module
#### Completion Date
**Date:** 2035-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2030-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-15

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-04-10
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-25
**Study First Submit QC Date:** 2024-04-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Gitte Fredberg Persson MD PhD

#### Responsible Party

**Investigator Affiliation:** Herlev Hospital

**Investigator Full Name:** Gitte Fredberg Persson MD PhD

**Investigator Title:** Associate Professor, Chief PhysicianGitte Fredberg Persson MD PhD

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Oligometastatic Disease

- Metastases

- Ablation Techniques

- Radiotherapy

- Stereotactic Radiation

- Surgery

**Keywords:**

- oligometastatic disease

- metastases-directed therapy

- metastasectomy

- thermal ablation

- stereotactic ablative radiotherapy

- stereotactic radiosurgery

- endpoints

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Discussion at multidisciplinary team conferences Lesion-specific treatment plan with allocation to

* surgical metastasectomy
* stereotactic radiotherapy
* thermal ablation
* electroporation

**Intervention Names:**

- Procedure: Local ablative therapy (LAT)

**Label:** Local ablative therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Local ablative therapy

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

**Name:** Local ablative therapy (LAT)

**Other Names:**

- Metastases-directed therapy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Time to failure of local ablative therapy (LAT) strategy

**Time Frame:** Assessed every 3-6 months for 5 years or life-long

#### Secondary Outcomes

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

**Measure:** Progression-free survival

**Time Frame:** Assessed every 3-6 months for 5 years or life-long

**Description:** 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

**Measure:** Time to widespread progression

**Time Frame:** Assessed every 3-6 months for 5 years or life-long

**Description:** 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

**Measure:** Freedom from systemic treatment

**Time Frame:** Assessed every 3-6 months for 5 years or life-long

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

**Measure:** Overall survival

**Time Frame:** Assessed every 3-6 months for 5 years or life-long

**Description:** Defined as time from first day of LAT to progression of the disease. Deaths from any cause are censored

**Measure:** Time to progression

**Time Frame:** Assessed every 3-6 months for 5 years or life-long

**Description:** Defined as time from first day of LAT to progression within the treated area. In case of doubt or disagreement, the case is reviewed at the local MDT conference. Deaths from any cause are censored

**Measure:** Time to local progression

**Time Frame:** 5 years or life-long

**Description:** Fractions of treated lesions which have not locally progressed at 1- and 3-years after local ablative therapy. Analysed per lesion, per patient, per treatment modality and per organ

**Measure:** Local lesion control rate at 1- and 3-years post-local ablative therapy

**Time Frame:** 3 years

**Description:** Defined as time from first day of LAT to progression outside the treatment field. Deaths from any cause are censored.

**Measure:** Time to distant progression

**Time Frame:** Assessed every 3-6 months for 5 years or life-long

**Description:** LAT related toxicity is defined as adverse events which are categorized by the local investigator as suspected expected or suspected unexpected due to LAT

**Measure:** Investigator reported grade 3-5 CTCAE (v.5.0) LAT related toxicity

**Time Frame:** 2 years

**Description:** Defined as LAT-related toxicity which occurs or is worsened within 3- months of end-of-treatment (EOT). LAT-related toxicity, which occurs or is worsened after the commencement of the LAT course but before EOT, is also registered as early toxicity.

**Measure:** Harms

**Time Frame:** Actively every 3-months for 2 years

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** michael.ruben.teindl.laursen@regionh.dk

**Name:** Michael RT Laursen, MD

**Phone:** +45 3868 9202

**Role:** CONTACT

**Contact 2:**

**Email:** Gitte.Persson@regionh.dk

**Name:** Gitte F Persson

**Phone:** +453868 9299

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Copenhagen

**Contacts:**

***Contact 1:***

- **Name:** Mette Pøhl, MD PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mette Pøhl, MD PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Maja Maraldo, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Morten Suppli, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Rene H Petersen, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Hans-Christian Pommergaard, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Søren Møller, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** Michael Achiam, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 9:***

- **Name:** Mikkel Rosendahl, MD PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Denmark

**Facility:** Copenhagen University Hospital Rigshospitalet

**State:** Capital Region Of Denmark

**Status:** NOT_YET_RECRUITING

**Zip:** 2100

**Location 2:**

**City:** Herlev

**Contacts:**

***Contact 1:***

- **Email:** michael.ruben.teindl.laursen@regionh.dk

- **Name:** Michael RT Laursen, MD

- **Phone:** +453868 9202

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mette Felter, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Henriette Lindberg, MD PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Eva Serup-Hansen, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Sebastian Krog, MD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Jesper Palshof, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Bodil Engelmann, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** Eva Ellebæk, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 9:***

- **Name:** Lisbet Hölmich, MD PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Denmark

**Facility:** Copenhagen University Hospital Herlev and Gentofte

**State:** Capital Region Of Denmark

**Status:** RECRUITING

**Zip:** 2730

**Location 3:**

**City:** Hillerød

**Contacts:**

***Contact 1:***

- **Name:** Maria Lendorf

- **Role:** CONTACT

***Contact 2:***

- **Name:** Maria Lendorf, MD PD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Hillerød Hospital

**State:** Capital Region Of Denmark

**Status:** NOT_YET_RECRUITING

**Zip:** 3400

**Location 4:**

**City:** Aarhus

**Contacts:**

***Contact 1:***

- **Email:** mettfode@rm.dk

- **Name:** Mette Marie Fode, MD PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mette Marie Fode, MD PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Azza Khalil, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Thomas Decker Christensen, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Ole Graumann, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Jørgen Bjerggaard Jensen, MD PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Denmark

**Facility:** Aarhus University Hospital

**State:** Central Denmark Region

**Status:** NOT_YET_RECRUITING

**Zip:** 8200

**Location 5:**

**City:** Herning

**Contacts:**

***Contact 1:***

- **Name:** Trine Øllegaard

- **Role:** CONTACT

***Contact 2:***

- **Name:** Trine Øllegaard, MD PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Gødstrup Hospital

**State:** Central Denmark Region

**Status:** NOT_YET_RECRUITING

**Zip:** 7400

**Location 6:**

**City:** Aarhus

**Contacts:**

***Contact 1:***

- **Name:** Britte Weber, MD PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Britta Weber, MD PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Danish Center for Particle Therapy

**State:** Central Region Denmark

**Status:** NOT_YET_RECRUITING

**Zip:** 8200

**Location 7:**

**City:** Aalborg

**Contacts:**

***Contact 1:***

- **Name:** Jimmy Søndergaard, MD PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Laurids Ø Poulsen, MD PhD

- **Role:** CONTACT

***Contact 3:***

- **Name:** Jimmi Søndergaard, MD PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Laurids Ø Poulsen, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Hella Sand, MSc

- **Role:** SUB_INVESTIGATOR

**Country:** Denmark

**Facility:** Aalborg University Hospital

**State:** Northern Region Of Denmark

**Status:** NOT_YET_RECRUITING

**Zip:** 9000

**Location 8:**

**City:** Odense

**Contacts:**

***Contact 1:***

- **Name:** Tine Schytte, MD PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Tine Schytte, MD PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Jørgen Johansen, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Christina Nyborg, MD PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Denmark

**Facility:** Odense University Hospital

**State:** Southern Denmark Region

**Status:** NOT_YET_RECRUITING

**Zip:** 5000

**Location 9:**

**City:** Sønderborg

**Country:** Denmark

**Facility:** Sønderborg Hospital

**State:** Southern Denmark Region

**Status:** NOT_YET_RECRUITING

**Zip:** 6400

**Location 10:**

**City:** Vejle

**Contacts:**

***Contact 1:***

- **Name:** Charlotte Kristiansen, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Charlotte Kristiansen, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Lars Fokdal, MD PhD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Lise Bentzen, MD PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Denmark

**Facility:** Vejle Hospital

**State:** Southern Denmark Region

**Status:** NOT_YET_RECRUITING

**Zip:** 7100

**Location 11:**

**City:** Roskilde

**Contacts:**

***Contact 1:***

- **Name:** Julie Gehl, MD DMSc

- **Role:** CONTACT

***Contact 2:***

- **Name:** Julie Gehl, MD DMSc

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Zealand University Hospital, Roskilde and Næstved

**State:** Zealand Region

**Status:** NOT_YET_RECRUITING

**Zip:** 4000

#### Overall Officials

**Official 1:**

**Affiliation:** Copenhagen University Hospital Herlev and Gentofte

**Name:** Gitte F Persson, MD PhD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Copenhagen University Hospital Herlev and Gentofte

**Name:** Michael RT Laursen, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** No specific access criteria

**Description:** Disease specific individual participant data will be available to the Danish Multidisciplinary Cancer Groups.

Modality specific individual participant data will be available for separate analysis.

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** The study protocol and the first draft of the SAP will be shared and available after the publication of the protocol article.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

### Misc Info Module

- Version Holder: 2024-05-24
