Trial Outcomes & Findings for Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. (NCT NCT00210106)

NCT ID: NCT00210106

Last Updated: 2021-05-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-05-18

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	52
Overall Study Safety Population	49
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	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
Overall Study Death	1
Overall Study Protocol Violation	13

Baseline Characteristics

Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy.

Baseline characteristics by cohort

Measure	Intraoperative Radiofrequency Ablation (IRFA) n=52 Participants 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
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment France	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Patients evaluable for efficacy (completed) : eligible, treated and with 2 scans available

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

Outcome measures

Measure	Intraoperative Radiofrequency Ablation (IRFA) n=38 Participants 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
Complete Hepatic Response Rate at 3 Months	79 percentage of participants Interval 63.0 to 90.0

SECONDARY outcome

Timeframe: at 1 and 2 years

Population: Patients evaluable for efficacy (completed) : eligible, treated and with 2 scans available

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.

Outcome measures

Measure	Intraoperative Radiofrequency Ablation (IRFA) n=38 Participants 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
Overall Survival OS rate at 1 year	97.4 percent probability of survival Interval 82.7 to 99.6
Overall Survival OS rate at 2 years	91.7 percent probability of survival Interval 76.3 to 97.2

SECONDARY outcome

Timeframe: at 1 and 2 years

Population: Patients evaluable for efficacy (completed) : eligible, treated and with 2 scans available

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.

Outcome measures

Measure	Intraoperative Radiofrequency Ablation (IRFA) n=38 Participants 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
Event-free Survival EFS rate at 1 year	18.4 percent probability of survival Interval 8.1 to 32.0
Event-free Survival EFS rate at 2 years	10.5 percent probability of survival Interval 3.3 to 22.5

Adverse Events

Intraoperative Radiofrequency Ablation (IRFA)

Serious events: 5 serious events

Other events: 6 other events

Deaths: 16 deaths

Serious adverse events

Measure	Intraoperative Radiofrequency Ablation (IRFA) n=49 participants at risk 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
Vascular disorders Thromboembolic event	2.0% 1/49 • Number of events 1 • 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.
Infections and infestations Hepatic infection	2.0% 1/49 • Number of events 1 • 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.
Hepatobiliary disorders Hepatic failure	2.0% 1/49 • Number of events 1 • 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.
Gastrointestinal disorders Intra-abdominal hemorrhage	2.0% 1/49 • Number of events 1 • 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.
Infections and infestations Sepsis	2.0% 1/49 • Number of events 1 • 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.

Other adverse events

Measure	Intraoperative Radiofrequency Ablation (IRFA) n=49 participants at risk 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
Gastrointestinal disorders Duodenal obstruction	6.1% 3/49 • Number of events 3 • 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.
Gastrointestinal disorders Intra-abdominal hemorrhage	6.1% 3/49 • Number of events 3 • 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.

Additional Information

Pr Serge Evrard

Digestive Tumours Unit, Institut Bergonie

Phone: s.evrard@brdeaux.unicancer.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place