Colorectal CancerARF2003NCT00210106
Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy.
A study testing Ablathermy in people with Colorectal Cancer, run by Institut Bergonié at 12 sites in France.
Trial summary
The hypothesis is that radiofrequency ablation combined or not with resection may allow a local control (the liver) in patients suffering from unresectable colorectal liver metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Ablathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 12 sitesFrance
- Study dates
- Jun 2003to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status < 2
Who cannot join
- -
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU d'Angers
Angers, 49000
Centre Saint Michel
Angoulême, 16000
CHU de Bordeaux
Bordeaux, 33076
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, 33076
Hopital Béclère
Clamart, 92140
Hopital Sub-Urbain du Bouscat
Le Bouscat, 33110
Hopital de la Croix Rousse
Lyon, 69000
Hopital Saint Eloi
Montpellier, 34000
Centre Hospitalier
Niort, 79000
Centre de Radiothérapie et d'Oncologie Médicale
Pau, 64000
Clinique Francheville
Périgueux, 24000
Clinique Mutualiste de Pessac
Pessac, 33600
About this study
Official title: Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. A Phase 2 Study.
The hypothesis is that radiofrequency ablation combined or not with resection may allow a local control (the liver) in patients suffering from unresectable colorectal liver metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.
- Conditions
- Colorectal Cancer
- Being tested
- Ablathermy
- Keywords
- Radiofrequency ablation, Colorectal cancer, Liver metastases
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblathermyDevice
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative radiofrequency ablation (IRFA) | Experimental | IRFA treatment, either with or without resection, was performed at laparotomy within 28 days of inclusion in the study. The type of IRFA current generator and probes, and whether or not resection was performed, was at the discretion of the surgeon. Receives: Device: Ablathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Hepatic Response Rate at 3 Months
Complete hepatic response (CHR) rate was defined as the absence of new hepatic lesions or contrast enhancement at the ablation and resection sites on CT performed at 2 and 3 months. CHR at 3 months was reported
Measured: 3 months
Secondary outcomes (2)
Overall Survival
OS was defined as the time from the treatment initiation to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. 1-year and 2-year OS rate were reported.
Measured: at 1 and 2 years
Event-free Survival
Event-free survival was measured from the date of intervention to the date of the first of the following events: initial failure, disease progression (hepatic or distant) or death (all causes). Patients who were alive and event-free were consored at the last documented date of follow-up. 1-year and 2-years EFS rates were reported.
Measured: at 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionDec 2008
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge EVRARD, Pr, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210106
- Sponsor's protocol ID
- IB2003-11
- Other IDs
- ARF2003
- Acronym
- ARF2003
- Status last verified
- Apr 2021
- First submitted
- 12 Sep 2005
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Evrard S, Rivoire M, Arnaud J-, Lermite E, Bellera C, Fonck M, Becouarn Y, Lalet C, Puildo M, Mathoulin-Pelissier S. Unresectable colorectal cancer liver metastases treated by intraoperative radiofrequency ablation with or without resection. Br J Surg. 2012 Apr;99(4):558-65. doi: 10.1002/bjs.8724. No abstract available.
PubMed 22396054
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. A Phase 2 Study.
- ClinicalTrials.gov ID
- NCT00210106
- Acronym / sponsor ID
- ARF2003 / IB2003-11
- Conditions
- Colorectal Cancer
- Keywords
- Radiofrequency ablation, Colorectal cancer, Liver metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that radiofrequency ablation combined or not with resection may allow a local control (the liver) in patients suffering from unresectable colorectal liver metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative radiofrequency ablation (IRFA) | Experimental | Device: AblathermyIRFA treatment, either with or without resection, was performed at laparotomy within 28 days of inclusion in the study. The type of IRFA current generator and probes, and whether or not resection was performed, was at the discretion of the surgeon. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status < 2
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Ablathermy | Device | Intraoperative radiofrequency ablation (IRFA) |
Primary outcome
Complete Hepatic Response Rate at 3 Months
Time frame: 3 months
Complete hepatic response (CHR) rate was defined as the absence of new hepatic lesions or contrast enhancement at the ablation and resection sites on CT performed at 2 and 3 months. CHR at 3 months was reported
2 secondary outcomes
Overall Survival
Time frame: at 1 and 2 years
Event-free Survival
Time frame: at 1 and 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22396054Evrard S, Rivoire M, Arnaud J-, Lermite E, Bellera C, Fonck M, Becouarn Y, Lalet C, Puildo M, Mathoulin-Pelissier S. Unresectable colorectal cancer liver metastases treated by intraoperative radiofrequency ablation with or without resection. Br J Surg. 2012 Apr;99(4):558-65. doi: 10.1002/bjs.8724. No abstract available.
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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.
Serge EVRARD, Pr principal investigator
Institut Bergonié
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablathermy in people with Colorectal Cancer, run by Institut Bergonié at 12 sites in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Hepatic Response Rate at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00210106, which also lists 1 linked publication.
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 18 May 2021.