Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02162563
Status:
RECRUITING
Last Update Posted:
2022-03-25
First Post:
2014-06-05
Brief Title:
Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases
Sponsor:
Dutch Colorectal Cancer Group
Organization:
Dutch Colorectal Cancer Group
Study Overview
Official Title:
Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases CAIRO5 a Randomized Phase 3 Study of the Dutch Colorectal Cancer Group DCCG
Status:
RECRUITING
Status Verified Date:
2022-03
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:
CAIRO5
Brief Summary:
Colorectal cancer patients with initially unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy However the optimal neoadjuvant induction regimen has not been defined and no consensus exist on criteria for resectability
In this study colorectal cancer patients with initially unresectable liver-only metastases as prospectively confirmed by an expert panel according to predefined criteria will be tested for RAS and BRAF tumor mutation status and selected by location of primary tumor Patients with RAS or BRAF mutant andor right sided tumors will be randomised between doublet chemotherapy FOLFOX or FOLFIRI plus bevacizumab schedule 1 and triple chemotherapy FOLFOXIRI plus bevacizumab schedule 2 Patients with RAS AND BRAF wildtype AND left-sided primary tumors will be randomized between doublet chemotherapy FOLFOX or FOLFIRI plus either bevacizumab schedule 1 or panitumumab schedule 3 Patient imaging will be reviewed for resectability by a central panel consisting of at least one radiologist and three surgeons every assessment Central panel review will be performed prior to randomization as well as during treatment as described in the protocol
In this study colorectal cancer patients with initially unresectable liver-only metastases as prospectively confirmed by an expert panel according to predefined criteria will be tested for RAS and BRAF tumor mutation status and selected by location of primary tumor Patients with RAS or BRAF mutant andor right sided tumors will be randomised between doublet chemotherapy FOLFOX or FOLFIRI plus bevacizumab schedule 1 and triple chemotherapy FOLFOXIRI plus bevacizumab schedule 2 Patients with RAS AND BRAF wildtype AND left-sided primary tumors will be randomized between doublet chemotherapy FOLFOX or FOLFIRI plus either bevacizumab schedule 1 or panitumumab schedule 3 Patient imaging will be reviewed for resectability by a central panel consisting of at least one radiologist and three surgeons every assessment Central panel review will be performed prior to randomization as well as during treatment as described in the protocol
Detailed Description:
Patients will be stratified for resectability of liver metastases potentially resectable versus permanently unresectable serum lactate dehydrogenase LDH normal versus abnormal BRAF mutation status wildtype versus mutated type of neoadjuvant chemotherapy FOLFIRI versus FOLFOX and hospital of registration
Patients with RAS and BRAF wildtype and left-sided primary tumors will be randomised between FOLFOX or FOLFIRI plus either bevacizumab or panitumumab The choice between FOLFOX or FOLFIRI is to the discretion of the local investigator however the treatment is restricted to regimens that are specified in the protocol Patients with RAS or BRAF mutated andor right-sided primary tumors will be randomized between FOLFOX FOLFIRI investigator choice plus bevacizumab or 5FU irinotecan oxaliplatin FOLFOXIRI plus bevacizumab
Patients will be evaluated every 8 weeks by CT scan for disease status The assigned systemic treatment should be continued for at least 6 months or earlier in case of resectability progression of disease unacceptable toxicity or patient refusal If after 6 months the panel concludes that the patient is still not resectable it is highly unlikely that resectability will be achieved at all Therefore the chemotherapy regimen may be reconsidered after 6 months of treatment These patients should continue with the targeted drug in combination with chemotherapy but the chemotherapy may be altered into a less toxic schedule such as fluoropyrimidine monotherapy The targeted drug should be continued until progression or unacceptable toxicity In patients who will become resectable and undergo secondary surgery of liver metastases the total duration of preoperative and postoperative treatment together should be 6 months with the chemotherapy schedule being administered according to the assigned treatment arm However in these patients the targeted drug bevacizumab or panitumumab should not be continued after surgery
Patients with RAS and BRAF wildtype and left-sided primary tumors will be randomised between FOLFOX or FOLFIRI plus either bevacizumab or panitumumab The choice between FOLFOX or FOLFIRI is to the discretion of the local investigator however the treatment is restricted to regimens that are specified in the protocol Patients with RAS or BRAF mutated andor right-sided primary tumors will be randomized between FOLFOX FOLFIRI investigator choice plus bevacizumab or 5FU irinotecan oxaliplatin FOLFOXIRI plus bevacizumab
Patients will be evaluated every 8 weeks by CT scan for disease status The assigned systemic treatment should be continued for at least 6 months or earlier in case of resectability progression of disease unacceptable toxicity or patient refusal If after 6 months the panel concludes that the patient is still not resectable it is highly unlikely that resectability will be achieved at all Therefore the chemotherapy regimen may be reconsidered after 6 months of treatment These patients should continue with the targeted drug in combination with chemotherapy but the chemotherapy may be altered into a less toxic schedule such as fluoropyrimidine monotherapy The targeted drug should be continued until progression or unacceptable toxicity In patients who will become resectable and undergo secondary surgery of liver metastases the total duration of preoperative and postoperative treatment together should be 6 months with the chemotherapy schedule being administered according to the assigned treatment arm However in these patients the targeted drug bevacizumab or panitumumab should not be continued after surgery
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-005435-24 | EUDRACT_NUMBER | None | None |