Radiofrequency Ablation Versus Stereotactic Radiotherapy... | NCT01233544

Studies
Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases

NCT01233544

Sponsor

University of Aarhus

Status

Terminated

Last Update Posted

May 12, 2016Estimated

Enrollment

300Estimated

Phase

Phase 3

Conditions

Colorectal Carcinoma
Liver Metastases

Interventions

SBRT or RFA

Countries

Denmark
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Nov 2, 2010

First Submission Date that Met QC Criteria

Nov 2, 2010

First Posted Date

Nov 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2016

Last Update Posted Date

May 12, 2016Estimated

Name	Class
Danish Center for Interventional Research in Radiation Oncology (CIRRO)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients with 1-4 inoperable colorectal liver metastases, no more 4 cm in diameter are randomized to either RFA or SBRT. Primary end point i local progression free survival. Chemotherapy is allowed before and after study treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SBRT or RFA	Procedure	Patients are allocated to one of the two arms in a 1:1 randomization	Radiofrequency ablation Stereotactic body radiation therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local progression-free survival		3 years

Secondary Outcomes

Measure	Description	Time Frame
Toxicity		3 years
Survival		3 years
Progression (local or distant)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adenocarcinoma of the colon or rectum
Liver metastases
Inoperable (technical or medical)
1-4 metastases
Maximum 40 mm in diameter
Suitable for both therapies, RFA and SBRT

Exclusion Criteria:

Uncontrolled extrahepatic disease and uncontrolled primary cancer
Liver cirrhosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morten Høyer, MD PhD	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus C		8000	Denmark
Karolinska Institute, Huddinge

Label	URL
Centre for Interventional Research in Radiation Oncology	View source

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016634	Radiosurgery
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided