Colorectal CarcinomaPhase 3RAS01NCT01233544
Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases
A Phase 3 study testing SBRT or RFA in people with Colorectal Carcinoma and Liver Metastases, run by University of Aarhus at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Carcinoma, Liver Metastases
- What is being tested?
- SBRT or RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2010to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled extrahepatic disease and uncontrolled primary cancer
- Liver cirrhosis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The International Liver Tumor Group RAS-trial Radiofrequency Ablation Versus Stereotactic Body Radiation Therapy for Colorectal Liver Metastases: A Randomized Trial
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.
Read the 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.
- Conditions
- Colorectal Carcinoma, Liver Metastases
- Being tested
- SBRT or RFA
- Keywords
- Colorectal carcinoma, Liver metastases, Stereotactic body radiation therapy, Radiofrequency ablation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT or RFAProcedure or surgery
Also called Stereotactic body radiation therapy, Radiofrequency ablation
Patients are allocated to one of the two arms in a 1:1 randomization
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Colorectal liver metastases treated by SBRT Receives: Procedure: SBRT or RFA |
| Radiofrequency ablation | Active comparator | Colorectal liver metastases treated by RFA Receives: Procedure: SBRT or RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local progression-free survival
Measured: 3 years
Secondary outcomes (4)
Toxicity
Measured: 3 years
Survival
Measured: 3 years
Progression (local or distant)
Measured: 3 years
Quality of life
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Responsible party
- Sponsor
- Investigators
- Morten Høyer, MD PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233544
- Sponsor's protocol ID
- RAS 01
- Acronym
- RAS01
- Status last verified
- May 2015
- First submitted
- 2 Nov 2010
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The International Liver Tumor Group RAS-trial Radiofrequency Ablation Versus Stereotactic Body Radiation Therapy for Colorectal Liver Metastases: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01233544
- Acronym / sponsor ID
- RAS01 / RAS 01
- Conditions
- Colorectal Carcinoma, Liver Metastases
- Keywords
- Colorectal carcinoma, Liver metastases, Stereotactic body radiation therapy, Radiofrequency ablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Study start
- Sep 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Procedure: SBRT or RFAColorectal liver metastases treated by SBRT |
| Radiofrequency ablation | Active comparator | Procedure: SBRT or RFAColorectal liver metastases treated by RFA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adenocarcinoma of the colon or rectum
- Liver metastases
- Inoperable (technical or medical)
- 1-4 metastases
- Maximum 40 mm in diameter
Key exclusion criteria (2 listed)
- Uncontrolled extrahepatic disease and uncontrolled primary cancer
- Liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT or RFAAlso: Stereotactic body radiation therapy, Radiofrequency ablationPatients are allocated to one of the two arms in a 1:1 randomization | Procedure or surgery | Radiofrequency ablation, Stereotactic body radiation therapy |
Primary outcome
Local progression-free survival
Time frame: 3 years
4 secondary outcomes
Toxicity
Time frame: 3 years
Survival
Time frame: 3 years
Progression (local or distant)
Time frame: 3 years
Quality of life
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Centre for Interventional Research in Radiation OncologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Høyer, MD PhD principal investigator
Aarhus University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SBRT or RFA in people with Colorectal Carcinoma and Liver Metastases, run by University of Aarhus at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.