Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185556
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-11-17
Brief Title:
COLDFIRE-III Trial Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
COLDFIRE-III Trial Perivascular and Peribiliary Colorectal Liver Metastases 0-5cm Irreversible Electroporation Versus Stereotactic Body Radiotherapy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLDFIRE-III
Brief Summary:
The primary objective of this phase IIbIII prospective randomized clinical trial is to compare the efficacy of irreversible electroporation IRE with stereotactic body radiotherapy SBRT in patients with perivascular or peribiliary colorectal liver metastases CRLM that are not amenable for surgical resection or thermal ablation Efficacy is assessed in terms of local control at 2 years
Detailed Description:
Rationale Currently the gold standard for perivascular and peribiliary colorectal liver metastases CRLM that are not amenable for surgical resection or thermal ablation is undetermined Two non-thermal treatment modalities could provide a solution for these anatomically challenging CRLM irreversible electroporation IRE and stereotactic body radiotherapy SBRT
IRE is a new minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation due to vicinity near vital structures such as vessels and bile ducts With IRE multiple electrical pulses are applied to tumorous tissue These pulses alter the existing transmembrane potential of the cell membranes and create nanopores after which the cell dies through loss of homeastasis SBRT is another non-thermal ablation modality and has important advantages over conventional radiotherapy such as a more precise and greater biological dose delivery and hence less toxicity and presumably better outcome
Study design The COLDFIRE-III trial is a phase IIBIII prospective randomized clinical trial The primary conducting center will be the Amsterdam UMC Amsterdam the Netherlands The purpose of this study is to assess and compare the efficacy of IRE and SBRT for perivascular or peribiliary CRLM in terms of local control at 2 years Other objectives are overall survival additional efficacy endpoints safety pain assessments and costs For the sample size calculations the log-rank test is used The 2-year survival proportion in group 1 a treatment group is 080 The proportion in group 2 the alternative treatment group is 055 The significance level of the test is 010 A total number of 78 patients will be randomized into one of two arms arm A IRE n 39 and arm B SBRT n 39
Study population 78 patients with 1-3 perivascular and peribiliary lesions of 0-5 cm ineligible for surgical resection and thermal ablation suitable for both IRE and SBRT and no or limited extrahepatic disease 1 extrahepatic lesion is allowed not including positive para-aortic lymph nodes celiac lymph nodes adrenal metastases pleural carcinomatosis or peritoneal carcinomatosis can be included Supplementary resections for resectable lesions and thermal ablations for unresectable CRLM are allowed A maximum number of 10 CRLM are allowed for patients with no extrahepatic disease and a maximum number of 5 lesions are allowed for patients with limited extrahepatic disease Eligible patients will be stratified according to tumor size 3cm vs 3-5 cm and induction chemotherapy prior to local treatment
Intervention Patients will be randomized into one of two arms arm A IRE and arm B SBRT The expert panel consisting of at least two interventional radiologists two radiation oncologists and two hepatobiliary surgeons will appoint lesions that are ineligible for surgery of thermal ablation and suitable for both IRE and SBRT as target lesions
IRE is a new minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation due to vicinity near vital structures such as vessels and bile ducts With IRE multiple electrical pulses are applied to tumorous tissue These pulses alter the existing transmembrane potential of the cell membranes and create nanopores after which the cell dies through loss of homeastasis SBRT is another non-thermal ablation modality and has important advantages over conventional radiotherapy such as a more precise and greater biological dose delivery and hence less toxicity and presumably better outcome
Study design The COLDFIRE-III trial is a phase IIBIII prospective randomized clinical trial The primary conducting center will be the Amsterdam UMC Amsterdam the Netherlands The purpose of this study is to assess and compare the efficacy of IRE and SBRT for perivascular or peribiliary CRLM in terms of local control at 2 years Other objectives are overall survival additional efficacy endpoints safety pain assessments and costs For the sample size calculations the log-rank test is used The 2-year survival proportion in group 1 a treatment group is 080 The proportion in group 2 the alternative treatment group is 055 The significance level of the test is 010 A total number of 78 patients will be randomized into one of two arms arm A IRE n 39 and arm B SBRT n 39
Study population 78 patients with 1-3 perivascular and peribiliary lesions of 0-5 cm ineligible for surgical resection and thermal ablation suitable for both IRE and SBRT and no or limited extrahepatic disease 1 extrahepatic lesion is allowed not including positive para-aortic lymph nodes celiac lymph nodes adrenal metastases pleural carcinomatosis or peritoneal carcinomatosis can be included Supplementary resections for resectable lesions and thermal ablations for unresectable CRLM are allowed A maximum number of 10 CRLM are allowed for patients with no extrahepatic disease and a maximum number of 5 lesions are allowed for patients with limited extrahepatic disease Eligible patients will be stratified according to tumor size 3cm vs 3-5 cm and induction chemotherapy prior to local treatment
Intervention Patients will be randomized into one of two arms arm A IRE and arm B SBRT The expert panel consisting of at least two interventional radiologists two radiation oncologists and two hepatobiliary surgeons will appoint lesions that are ineligible for surgery of thermal ablation and suitable for both IRE and SBRT as target lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None