Actively Recruiting
National Longitudinal Study of Local Ablative Therapy for Oligometastatic Disease Including Both Interventional and Observational Approaches
Led by Gitte Fredberg Persson MD PhD · Updated on 2024-04-16
1200
Participants Needed
11
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with oligometastatic disease (OMD) from any non-blood cancer to understand how local treatments aimed at targeting metastases work over time. The purpose is to track the success duration of various local ablative therapies (LAT) such as surgery, radiotherapy, thermal ablation, and electroporation across different cancer types and metastatic sites. This national, multicenter study combines both observational and interventional approaches to assess treatment impact and patient outcomes. Patients receive local ablative therapy using one or more methods including surgical removal of metastases, stereotactic radiotherapy, thermal ablation, or electroporation. Treatment decisions are made by a multidisciplinary team and may involve standard or non-standard LAT based on clinical relevance. The study includes an observational group treated according to standard care guidelines and an interventional group receiving non-standard LAT. Patients may undergo multiple LAT treatments if their disease remains suitable for such interventions. Participants are followed over time with regular assessments every 3 to 6 months for up to 5 years or longer. Evaluations include imaging scans and clinical reviews to measure time until LAT strategy failure, progression-free survival, overall survival, local and distant tumor control, and treatment side effects. Safety is closely monitored with toxicity reports collected every 3 months for the first 2 years. The study continues patient follow-up until death or withdrawal, aiming to better understand long-term outcomes and improve treatment planning for OMD.
CONDITIONS
Brief Title
Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histology or cytology confirmed non-hematological cancer
- Stage IV disease
- ECOG performance status of 2 or less
- Life expectancy greater than 6 months
- Baseline PET-CT, CT, or MRI scan within 42 days of inclusion (preferably within 28 days)
- Controlled primary tumor or planned local ablative therapy if progressing
- Oligometastatic disease with up to five metastases or clustered lesions per ESTRO-EORTC classification
- All visible metastatic lesions planned for definitive local ablative therapy
- Local ablative therapy deemed clinically relevant and documented by treating physicians or multidisciplinary team
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Pregnancy
- Diffuse cancer not amenable to local ablative therapy (e.g., leptomeningeal carcinomatosis, malignant pleural or peritoneal effusions, lymphangitic carcinomatosis)
- Local ablative therapy deemed unsafe by multidisciplinary team (e.g., tumor perforation risk)
- For stereotactic radiotherapy patients, lesion size exceeding safe treatment limits (generally over 5 cm)
- Radiation dose constraints exceeded due to prior radiotherapy at treatment site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Varies according to treatment plan
Participants receive local ablative therapy (LAT) including surgical metastasectomy, stereotactic radiotherapy, thermal ablation, or electroporation to all oligometastatic lesions as planned by a multidisciplinary team.
Treatment visits as scheduled per lesion-specific therapy
Duration - Up to 5 years or life-long
Participants are followed up with assessments every 3 to 6 months for up to 5 years or longer to monitor treatment outcomes and safety.
Visits every 3 to 6 months for up to 5 years or longer
Trial Site Locations
Total: 11 locations
1
Copenhagen University Hospital Rigshospitalet
Copenhagen, Capital Region of Denmark, Denmark, 2100
Not Yet Recruiting
2
Copenhagen University Hospital Herlev and Gentofte
Herlev, Capital Region of Denmark, Denmark, 2730
Actively Recruiting
3
Hillerød Hospital
Hillerød, Capital Region of Denmark, Denmark, 3400
Not Yet Recruiting
4
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8200
Not Yet Recruiting
5
Gødstrup Hospital
Herning, Central Jutland, Denmark, 7400
Not Yet Recruiting
6
Danish Center for Particle Therapy
Aarhus, Central Region Denmark, Denmark, 8200
Not Yet Recruiting
7
Aalborg University Hospital
Aalborg, Northern Region of Denmark, Denmark, 9000
Not Yet Recruiting
8
Zealand University Hospital, Roskilde and Næstved
Roskilde, Region Sjælland, Denmark, 4000
Not Yet Recruiting
9
Odense University Hospital
Odense, Southern Denmark Region, Denmark, 5000
Not Yet Recruiting
10
Sønderborg Hospital
Sønderborg, Southern Denmark Region, Denmark, 6400
Not Yet Recruiting
11
Vejle Hospital
Vejle, Southern Denmark Region, Denmark, 7100
Not Yet Recruiting
Research Team
M
Michael RT Laursen, MD
G
Gitte F Persson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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