Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555003
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
DEBIRI Plus Chemotherapy vs Chemotherapy Alone in Colorectal Cancer Liver Metastases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Analysis of the Efficacy of Irinotecan-loaded Drug-eluting Beads DEBIRI in Combination With Systemic Chemotherapy Versus Chemotherapy Alone in Unresectable Colorectal Cancer Liver Metastases a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEAR-DEBIRI
Brief Summary:
A total of 116 patients who meet the inclusion criteria and are chemotherapy-naïve for their metastatic disease will be randomly assigned to either the treatment group DEBIRI plus systemic chemotherapy or the control group systemic chemotherapy alone
After 4 cycles of chemotherapy and 2 cycles of DEBIRI patient reassessment to evaluate treatment response based on RECIST criteria will be performed using MRI or CT scan within 1-3 months of treatment initiation
The feasibility of secondary tumor resection as primary endpoint will be reassessed at a three-month follow-up multidisciplinary team MDT meeting guided by established clinical guidelines
After 4 cycles of chemotherapy and 2 cycles of DEBIRI patient reassessment to evaluate treatment response based on RECIST criteria will be performed using MRI or CT scan within 1-3 months of treatment initiation
The feasibility of secondary tumor resection as primary endpoint will be reassessed at a three-month follow-up multidisciplinary team MDT meeting guided by established clinical guidelines
Detailed Description:
Upon acquiring ethical approval patients with histologically proven unresectable or borderline resectable liver metastases from colorectal origin who are referred to the hepatobiliary clinic between September 2024 and September 2026 will be enrolled to the study Informed consent will be obtained for their participation prior to enrollment
A total of 116 patients who are chemotherapy-naïve for their metastatic disease will be randomly assigned to either the treatment group or the control group
With the aim of controlling major confounding factors Stratified randomization will be performed based on synchronousmetachronous liver metastases and unresectableborderline resectable status
Targeted therapy administration for each treatment group in based on oncologists decision and will be tailored to the tumors biological characteristics and the patients clinical status Ultimately patients will be categorized into one of the two following treatment groups
Group 1 DEBIRI standard systemic chemotherapy Targeted therapy Group 2 Standard systemic chemotherapy Targeted therapy The Tumor characteristics including the number size and anatomical location as well as the presence or absence of extrahepatic metastases will be assessed based on initial imaging MRI
The treatment protocol is defined as the administration of a chemotherapy regimen on days 0 and 14 followed by DEBIRI on days 7 and 21 Each patient of the treatment arm will receive at least two doses of DEBIRI unless treatment-limiting adverse events occur
After 4 cycles of chemotherapy and 2 cycles of DEBIRI patient reassessment to evaluate treatment response will be performed using MRI or CT scan within 1-3 months of treatment initiation All imagings will be reviewed by 2 radiologists who are blinded to clinical information regarding treatment arm Treatment response will be determined using RECIST criteria
Conversion to resectability as primary endpoint will be evaluated at a three-month follow-up multidisciplinary team MDT meeting guided by established clinical guidelines
Secondary endpoints of the study will encompass evaluation of treatment tolerability and adverse event rate alongside analyzing progression-free survival and overall survival
A total of 116 patients who are chemotherapy-naïve for their metastatic disease will be randomly assigned to either the treatment group or the control group
With the aim of controlling major confounding factors Stratified randomization will be performed based on synchronousmetachronous liver metastases and unresectableborderline resectable status
Targeted therapy administration for each treatment group in based on oncologists decision and will be tailored to the tumors biological characteristics and the patients clinical status Ultimately patients will be categorized into one of the two following treatment groups
Group 1 DEBIRI standard systemic chemotherapy Targeted therapy Group 2 Standard systemic chemotherapy Targeted therapy The Tumor characteristics including the number size and anatomical location as well as the presence or absence of extrahepatic metastases will be assessed based on initial imaging MRI
The treatment protocol is defined as the administration of a chemotherapy regimen on days 0 and 14 followed by DEBIRI on days 7 and 21 Each patient of the treatment arm will receive at least two doses of DEBIRI unless treatment-limiting adverse events occur
After 4 cycles of chemotherapy and 2 cycles of DEBIRI patient reassessment to evaluate treatment response will be performed using MRI or CT scan within 1-3 months of treatment initiation All imagings will be reviewed by 2 radiologists who are blinded to clinical information regarding treatment arm Treatment response will be determined using RECIST criteria
Conversion to resectability as primary endpoint will be evaluated at a three-month follow-up multidisciplinary team MDT meeting guided by established clinical guidelines
Secondary endpoints of the study will encompass evaluation of treatment tolerability and adverse event rate alongside analyzing progression-free survival and overall survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None