Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356779
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-25
Brief Title:
Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease
Sponsor:
Gitte Fredberg Persson MD PhD
Organization:
Herlev Hospital
Study Overview
Official Title:
A National Longitudinal Study of Metastases-directed Local Ablative Therapy for Patients With Oligometastatic Disease - a Combined Interventional and Observational Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OLIGO-DK
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None