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| ID | Type | Description | Link |
|---|---|---|---|
| ARF2003 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablathermy | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 1 and 2 years |
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Inclusion Criteria:
Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status < 2
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Serge EVRARD, Pr | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49000 | France | |||
| Centre Saint Michel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22396054 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intraoperative Radiofrequency Ablation (IRFA) | 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. Ablathermy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | at 1 and 2 years |
| Angoulême |
| 16000 |
| France |
| CHU de Bordeaux | Bordeaux | 33076 | France |
| Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | Bordeaux | 33076 | France |
| Hopital Béclère | Clamart | 92140 | France |
| Hopital Sub-Urbain du Bouscat | Le Bouscat | 33110 | France |
| Hopital de la Croix Rousse | Lyon | 69000 | France |
| Hopital Saint Eloi | Montpellier | 34000 | France |
| Centre Hospitalier | Niort | 79000 | France |
| Centre de Radiothérapie et d'Oncologie Médicale | Pau | 64000 | France |
| Clinique Mutualiste de Pessac | Pessac | 33600 | France |
| Clinique Francheville | Périgueux | 24000 | France |
| Safety Population | safety population is defined as patients who received IRFA treatment with our without resection. |
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| COMPLETED | Patients eligible (without major protocol deviation) who received the treatment (IRFA +/- surgery) and for whom 2 scans (2 months and 3 months) were available. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intraoperative Radiofrequency Ablation (IRFA) | 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. Ablathermy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Patients evaluable for efficacy (completed) : eligible, treated and with 2 scans available | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months |
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| Secondary | 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. | Patients evaluable for efficacy (completed) : eligible, treated and with 2 scans available | Posted | Number | 95% Confidence Interval | percent probability of survival | at 1 and 2 years |
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| Secondary | 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. | Patients evaluable for efficacy (completed) : eligible, treated and with 2 scans available | Posted | Number | 95% Confidence Interval | percent probability of survival | at 1 and 2 years |
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Adverse events were collected/monitored within 30 days after treatment and within 3 months post-treatment and deaths were monitored/assessed for up to 2 years post-treatment for each participant (in the scope of survival assessment)
All adverse events observed in study participants were defined by the Clavien-Dindo classification system of surgical complications.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intraoperative Radiofrequency Ablation (IRFA) | 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. Ablathermy | 16 | 49 | 5 | 49 | 6 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic event | Vascular disorders | CTCAE V4.0 | Systematic Assessment |
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| Hepatic infection | Infections and infestations | CTCAE V4.0 | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | CTCAE V4.0 | Systematic Assessment |
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| Intra-abdominal hemorrhage | Gastrointestinal disorders | CTCAE V4.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE V4.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal obstruction | Gastrointestinal disorders | CTCAE V4.0 | Systematic Assessment |
| |
| Intra-abdominal hemorrhage | Gastrointestinal disorders | CTCAE V4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Serge Evrard | Digestive Tumours Unit, Institut Bergonie | s.evrard@brdeaux.unicancer.fr |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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