Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06356779

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

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

Follow-up

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

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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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