Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease

NCT06356779 | Recruiting

• 1 other identifier: H-23066725
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 11

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.

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

Outcome Measures

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

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

Secondary Outcomes (10)

• Progression-free survival

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

• Time to widespread progression

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

• Freedom from systemic treatment

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

• Overall survival

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

• Time to progression

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

Study Arms (1)

Local ablative therapy

EXPERIMENTAL

Discussion at multidisciplinary team conferences Lesion-specific treatment plan with allocation to * surgical metastasectomy * stereotactic radiotherapy * thermal ablation * electroporation

Procedure: Local ablative therapy (LAT)

Interventions

Local ablative therapy (LAT) PROCEDURE

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

Also known as: Metastases-directed therapy

Local ablative therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histology or cytology proven non-haematological cancer
• Stage IV disease
• ECOG performance status ≤ 2
• Life expectancy \> 6 months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gitte Fredberg Persson MD PhD: lead

Study Sites (11)

Copenhagen University Hospital Rigshospitalet

Copenhagen, Capital Region of Denmark, 2100, Denmark

NOT YET RECRUITING

Copenhagen University Hospital Herlev and Gentofte

Herlev, Capital Region of Denmark, 2730, Denmark

RECRUITING

Hillerød Hospital

Hillerød, Capital Region of Denmark, 3400, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

NOT YET RECRUITING

Gødstrup Hospital

Herning, Central Jutland, 7400, Denmark

NOT YET RECRUITING

Danish Center for Particle Therapy

Aarhus, Central Region Denmark, 8200, Denmark

NOT YET RECRUITING

Aalborg University Hospital

Aalborg, Northern Region of Denmark, 9000, Denmark

NOT YET RECRUITING

Zealand University Hospital, Roskilde and Næstved

Roskilde, Region Sjælland, 4000, Denmark

NOT YET RECRUITING

Odense University Hospital

Odense, Southern Denmark Region, 5000, Denmark

NOT YET RECRUITING

Sønderborg Hospital

Sønderborg, Southern Denmark Region, 6400, Denmark

NOT YET RECRUITING

Vejle Hospital

Vejle, Southern Denmark Region, 7100, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gitte F Persson, MD PhD

  Copenhagen University Hospital Herlev and Gentofte

  STUDY CHAIR

• Michael RT Laursen, MD

  Copenhagen University Hospital Herlev and Gentofte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael RT Laursen, MD

CONTACT

+45 3868 9202; michael.ruben.teindl.laursen@regionh.dk

Gitte F Persson

CONTACT

+453868 9299; Gitte.Persson@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Chief PhysicianGitte Fredberg Persson MD PhD

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 10, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol and the first draft of the SAP will be shared and available after the publication of the protocol article.
• Access Criteria: No specific access criteria

Locations

DK (11)