NCT01233544

Brief Summary

This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma liver metastases. Primary end point is local progression free survival.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2010

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
terminated

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 Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2015

Enrollment Period

4.3 years

First QC Date

November 2, 2010

Last Update Submit

May 11, 2016

Conditions

Colorectal CarcinomaLiver Metastases

Keywords

Colorectal carcinomaLiver metastasesStereotactic body radiation therapyRadiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • Local progression-free survival

    3 years

Secondary Outcomes (4)

  • Toxicity

    3 years

  • Survival

    3 years

  • Progression (local or distant)

    3 years

  • Quality of life

    3 years

Study Arms (2)

Stereotactic body radiation therapy

EXPERIMENTAL

Colorectal liver metastases treated by SBRT

Procedure: SBRT or RFA

Radiofrequency ablation

ACTIVE COMPARATOR

Colorectal liver metastases treated by RFA

Procedure: SBRT or RFA

Interventions

SBRT or RFAPROCEDURE

Patients are allocated to one of the two arms in a 1:1 randomization

Also known as: Stereotactic body radiation therapy, Radiofrequency ablation
Radiofrequency ablationStereotactic body radiation therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adenocarcinoma of the colon or rectum
  • Liver metastases
  • Inoperable (technical or medical)
  • metastases
  • Maximum 40 mm in diameter
  • Suitable for both therapies, RFA and SBRT

You may not qualify if:

  • Uncontrolled extrahepatic disease and uncontrolled primary cancer
  • Liver cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Karolinska Institute, Huddinge

Stockholm, 141 86, Sweden

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

RadiosurgeryRadiofrequency Ablation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesRadiofrequency TherapyAblation Techniques

Study Officials

  • Morten Høyer, MD PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 3, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 12, 2016

Record last verified: 2015-05

Locations

DK(1)SE(1)