Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501482
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-27
Brief Title:
Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Interest of Postoperative Reintroduction of Chemotherapy in Patients Undergoing Resection of Colorectal Liver Metastases After Good Response to FOLFIRI-based Chemotherapy With or Without Targeted Agent Intergroup FRENCH- PRODIGE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
IRIMAD
Brief Summary:
Eligible patients are patients with contraindication to preoperative oxaliplatin based-chemotherapy who underwent resection of no more than 10 colorectal liver metastases after preoperative FOLFIRI based chemotherapy with or without targeted agents These patients must have objective response to treatment radiologic or pathologic response The standard care for these patients is no postoperative treatment although benefit of reintroduction of FOLFIRI chemotherapy in good responders could be expected
This study is a National multicenter open-label randomized 2-arm phase III superiority trial comparing postoperative reintroduction of FOLFIRI based-chemotherapy experimental arm vs no treatment control arm in patients undergoing resection of colorectal liver metastases after good response to FOLFIRI-based chemotherapy with or without targeted agent
The primary endpoint of the study is 3-year disease free survival Based on published data 3-year DFS in control group absence of postoperative treatment is 25 Expected 3-year DFS in the experimental group is 40 The study will randomize 254 patients 127 in the chemotherapy group and 127 in the no treatment group in 30 french academic centers
This study is a National multicenter open-label randomized 2-arm phase III superiority trial comparing postoperative reintroduction of FOLFIRI based-chemotherapy experimental arm vs no treatment control arm in patients undergoing resection of colorectal liver metastases after good response to FOLFIRI-based chemotherapy with or without targeted agent
The primary endpoint of the study is 3-year disease free survival Based on published data 3-year DFS in control group absence of postoperative treatment is 25 Expected 3-year DFS in the experimental group is 40 The study will randomize 254 patients 127 in the chemotherapy group and 127 in the no treatment group in 30 french academic centers
Detailed Description:
This study is a National multicenter open-label randomized 2-arm phase III superiority trial comparing postoperative reintroduction of FOLFIRI based-chemotherapy experimental arm vs no treatment control arm in patients undergoing resection of colorectal liver metastases after good response to FOLFIRI-based chemotherapy with or without targeted agent
Inclusion criteria are
Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons For this study metachronous CLM is defined as liver recurrence occurring more than 12 months after treatment of the primary colorectal cancer
No more than 10 treated CLM at surgery
At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy targeted therapy
Preoperative FOLFIRI based chemotherapy targeted therapy administered no more than 12 weeks before surgery
R0R1resection radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease
Objective response to preoperative therapy defined as complete or partial radiological response andor major or complete pathologic response
No extrahepatic or residual liver disease on baseline work-up including thoraco-abdominal CT scan within 6 weeks after surgery 1 non-specific lung nodule of less than 10 mm in maximum diameter is not considered as extra-hepatic metastases
Primary tumor or liver metastasis of CRC must be characterized for RAS and BRAF status
No contraindication to FOLFIRI based chemotherapy
Patients must be 18 years old or older
A WHO performance status of 0 or 1
Participants must be affiliated to a social security scheme The primary objective is demonstrate an improvement of disease-free survival rate at 3 years
In the experimental arm patients will be treated with irinotecan 180 mgm2 leucovorin 400 mgm2 at day 1 then 5-FU 400 mgm2 bolus followed by 2400 mgm2 continuous infusion over 46 h biweekly For a total of 12 cycles of perioperative chemotherapy including the preoperative chemotherapy
In the control arm patients do not receive any adjuvant treatment This is an intention-to-treat trial Based on published data 3-year DFS in the control arm is 25 Expected 3-year DFS in the experimental group is 40 The sample size in each group is 127 with a total number of 185 events required an exponential maximum likelihood test of equality of survival curves with a 0050 two-sided significance level will have 80 power to detect the difference between groups constant hazard-ratio of 0662 assuming a 36 month length of accrual period a 72 maximum length of follow up and 5 annual attrition following exponential model over study period following exponential model over study period
Inclusion criteria are
Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons For this study metachronous CLM is defined as liver recurrence occurring more than 12 months after treatment of the primary colorectal cancer
No more than 10 treated CLM at surgery
At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy targeted therapy
Preoperative FOLFIRI based chemotherapy targeted therapy administered no more than 12 weeks before surgery
R0R1resection radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease
Objective response to preoperative therapy defined as complete or partial radiological response andor major or complete pathologic response
No extrahepatic or residual liver disease on baseline work-up including thoraco-abdominal CT scan within 6 weeks after surgery 1 non-specific lung nodule of less than 10 mm in maximum diameter is not considered as extra-hepatic metastases
Primary tumor or liver metastasis of CRC must be characterized for RAS and BRAF status
No contraindication to FOLFIRI based chemotherapy
Patients must be 18 years old or older
A WHO performance status of 0 or 1
Participants must be affiliated to a social security scheme The primary objective is demonstrate an improvement of disease-free survival rate at 3 years
In the experimental arm patients will be treated with irinotecan 180 mgm2 leucovorin 400 mgm2 at day 1 then 5-FU 400 mgm2 bolus followed by 2400 mgm2 continuous infusion over 46 h biweekly For a total of 12 cycles of perioperative chemotherapy including the preoperative chemotherapy
In the control arm patients do not receive any adjuvant treatment This is an intention-to-treat trial Based on published data 3-year DFS in the control arm is 25 Expected 3-year DFS in the experimental group is 40 The sample size in each group is 127 with a total number of 185 events required an exponential maximum likelihood test of equality of survival curves with a 0050 two-sided significance level will have 80 power to detect the difference between groups constant hazard-ratio of 0662 assuming a 36 month length of accrual period a 72 maximum length of follow up and 5 annual attrition following exponential model over study period following exponential model over study period
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504831-42-00 | CTIS | None | None |