Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06356779

Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease

Led by Gitte Fredberg Persson MD PhD · Updated on 2024-04-16

1200

Participants Needed

11

Research Sites

611 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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 proven non-haematological cancer
  • Stage IV disease
  • ECOG performance status 64; 2
  • Life expectancy > 6 months
  • A baseline scan (PET-CT, CT, or MRI) within 42 days of inclusion
  • Controlled primary tumor or planned local ablative therapy if progressing
  • Oligometastatic disease with up to 5 metastases, including oligoprogression
  • All oligometastatic lesions planned for definitive local ablative therapy
  • Local ablative therapy deemed clinically relevant by treating or multidisciplinary team
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Diffuse cancer that cannot be locally ablated (e.g., leptomeningeal carcinomatosis, malignant pleural effusions, lymphangitic carcinomatosis, peritoneal carcinomatosis)
  • Local ablative therapy deemed unsafe by multidisciplinary team
  • For patients receiving stereotactic radiotherapy, metastatic lesions larger than 5 cm or exceeding radiation dose constraints if previously treated

AI-Screening

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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

CONTACT

G

Gitte F Persson

CONTACT

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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