Colorectal Cancer
Conditions
Keywords
Radiofrequency ablation, Colorectal cancer, Liver metastases
Brief 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.
Interventions
DEVICEAblathermy
Sponsors
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status \< 2
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Hepatic Response Rate at 3 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | at 1 and 2 years | 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. |
| Event-free Survival | at 1 and 2 years | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Protocol Violation | 13 |
Baseline characteristics
| Characteristic | Intraoperative Radiofrequency Ablation (IRFA) |
|---|---|
| Age, Continuous | 60 years |
| Region of Enrollment France | 52 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 49 |
| other Total, other adverse events | 6 / 49 |
| serious Total, serious adverse events | 5 / 49 |
Outcome results
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
Time frame: 3 months
Population: Patients evaluable for efficacy (completed) : eligible, treated and with 2 scans available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intraoperative Radiofrequency Ablation (IRFA) | Complete Hepatic Response Rate at 3 Months | 79 percentage of participants |
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.
Time frame: at 1 and 2 years
Population: Patients evaluable for efficacy (completed) : eligible, treated and with 2 scans available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intraoperative Radiofrequency Ablation (IRFA) | Event-free Survival | EFS rate at 1 year | 18.4 percent probability of survival |
| Intraoperative Radiofrequency Ablation (IRFA) | Event-free Survival | EFS rate at 2 years | 10.5 percent probability of survival |
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.
Time frame: at 1 and 2 years
Population: Patients evaluable for efficacy (completed) : eligible, treated and with 2 scans available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intraoperative Radiofrequency Ablation (IRFA) | Overall Survival | OS rate at 1 year | 97.4 percent probability of survival |
| Intraoperative Radiofrequency Ablation (IRFA) | Overall Survival | OS rate at 2 years | 91.7 percent probability of survival |