NCT04798898

Brief Summary

To examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Nov 2022Dec 2026

First Submitted

Initial submission to the registry

March 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 14, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 5, 2024

Status Verified

November 1, 2024

Enrollment Period

2.5 years

First QC Date

March 9, 2021

Last Update Submit

December 4, 2024

Conditions

Liver Metastasis Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Median survival in each arm

    3 years

Secondary Outcomes (4)

  • One-year survival

    1 year

  • Two-year survival

    2 years

  • Three-year survival

    3 years

  • Recurrence rate

    1, 2, and 3 years

Other Outcomes (1)

  • Complications

    30-day postoperatively

Study Arms (2)

Intervention (+RFA) arm

EXPERIMENTAL

Preoperative partial RFA necrosis in the liver metastasis followed by liver resection

Device: RFA (radiofrequency ablation)

Control (-RFA) arm

NO INTERVENTION

Liver resection

Interventions

RFA (radiofrequency ablation)DEVICE

Preoperative RFA-induced partial necrosis of the liver metastasis

Intervention (+RFA) arm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with colorectal liver metastases planned for resection
  • At least one tumor size \>=3cm
  • Performance status 0-1

You may not qualify if:

  • Liver cirrhosis
  • Extrahepatic metastases that can not be addressed curatively
  • Other malignant diseases within 5 years prior to diagnosis
  • Prior RFA treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Surgery

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Frank V Mortensen, MD, DMSc

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Kirkegård, MD, PhD

CONTACT

+4524995027jakob.kirkegaard@auh.rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 15, 2021

Study Start

November 14, 2022

Primary Completion

June 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

December 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)