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PANIRINOX : Phase II randomized study comparing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510645-34-00
Acronym
UC-0110/1608
Enrollment
225
Registered
2024-03-22
Start date
2017-06-28
Completion date
Unknown
Last updated
2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RAS and B-RAF wild-type metastatic colorectal cancer. RAS and B-RAF mutation will be determined using circulating cell-free DNA (ccfDNA) by IntPlex method

Brief summary

Complete response rate where complete response is defined as complete disappearance of metastatic lesions after maximum of 12 cycles of chemotherapy and tumor marker level normalization (CEA). Complete disappearance of metastatic lesions will be assessed according to RECIST criteria version 1.1: Disappearance of all target and non-target lesions on the same method of assessment that at baseline (CT Scan or MRI). Every complete response will have to be confirmed 4 to 6 weeks after the last trt

Detailed description

Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause, Progression-Free Survival (PFS) is defined as the time from the date of randomization to the date of documented progression or any cause of death. Progression will be assessed by CT scan or MRI according to RECIST criteria version 1.1, Secondary resection rate is defined as the percentage of patients with initially irresectable metastases who will have a secondary resection R0 or R1 of their metastases, Early tumor shrinkage (ETS) is defined as the relative change in the sum of longest diameters of RECIST target lesions after 4 cycles compared to baseline, Depth of response (DpR) is defined as the relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, as compared to baseline, Adverse events rate will be graded based on NCI CTCAE v4.03 classification, Diagnostic performance of ccfDNA analysis compared to the tumor-tissue analysis (current gold standard)

Interventions

DRUGOXALIPLATIN
DRUGIRINOTECAN
DRUGFOLINIC ACID
DRUGCALCIUM LEVOFOLINATE
DRUGFLUOROURACIL

Sponsors

Unicancer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Complete response rate where complete response is defined as complete disappearance of metastatic lesions after maximum of 12 cycles of chemotherapy and tumor marker level normalization (CEA). Complete disappearance of metastatic lesions will be assessed according to RECIST criteria version 1.1: Disappearance of all target and non-target lesions on the same method of assessment that at baseline (CT Scan or MRI). Every complete response will have to be confirmed 4 to 6 weeks after the last trt

Secondary

MeasureTime frame
Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause, Progression-Free Survival (PFS) is defined as the time from the date of randomization to the date of documented progression or any cause of death. Progression will be assessed by CT scan or MRI according to RECIST criteria version 1.1, Secondary resection rate is defined as the percentage of patients with initially irresectable metastases who will have a secondary resection R0 or R1 of their metastases, Early tumor shrinkage (ETS) is defined as the relative change in the sum of longest diameters of RECIST target lesions after 4 cycles compared to baseline, Depth of response (DpR) is defined as the relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, as compared to baseline, Adverse events rate will be graded based on NCI CTCAE v4.03 classification, Diagnostic perf

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026