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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. - UCGI28_PANIRINOX

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001490-33-FR

Enrollment

209

Registered

2016-11-23

Start date

2016-10-25

Completion date

Unknown

Last updated

2024-04-02

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. MedDRA version: 19.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864

Interventions

Trade Name: Vectibix Pharmaceutical Form: Solution for infusion INN or Proposed INN: PANITUMUMAB CAS Number: 339177-26-3 Trade Name: Oxaliplatine Pharmaceutical Form: Powder for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years 2. ECOG PS between 0 and 1 3. Histologically confirmed adenocarcinoma of the colon or rectum 4. Untreated synchronous or metachronous metastatic disease deemed unresectable with curative intent 5. K-Ras (codons 12, 13, 59, 61, 117, 146), N-Ras (codons 12, 13, 59, 61) and B-Raf (codon 600) wild-type tumor status according to plasma analysis of circulating cell free DNA by Intplex technology 6. Measurable disease according to RECIST version 1.1 7. Adequate hematologic, hepatic and renal functions: • Absolute neutrophil count (ANC) =1.5 x 109/L • Haemoglobin =9 g/dL • Platelets (PTL) =100 x 109/L • AST/ALT =5 x ULN • Alkaline phosphatase =2.5 x ULN • Bilirubin =1.5 x ULN • Creatinine clearance =50 mL/min (Cockcroft and Gault formula) 8. Life expectancy of at least 3 months 9. Adequate contraception if applicable 10. Patient affiliated to a social security regimen 11. Patient information and signed written consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 108

Exclusion criteria

Exclusion criteria: 1. History of other malignancy within the previous 5 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma) 2. Adjuvant treatment with oxaliplatin 3. Previous treatment for metastatic disease 4. Patients who received any chemo- and/or radiotherapy within 15 days from the date of blood sampling for the RAS and BRAF test 5. Brain metastases 6. Patients with a history of severe or life-threatening hypersensitivity to the active substances or to any of the excipients delivered in this study 7. Patient with history of pulmonary fibrosis or interstitial pneumonitis 8. Previous organ transplantation, HIV or other immunodeficiency syndromes 9. Concomitant medications/comorbidities that may prevent the patient from receiving study treatment as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, symptomatic congestive heart failure, uncontrolled hypertension…) 10. Persistent peripheral neuropathy >grade1 (NCI CT v4.03) 11. Other concomitant cancer 12. Patient participating another clinical trial 13. Pregnant woman or lactating woman 14. Patients with psychological, familial, sociological or geographical condition hampering compliance with the study protocol and follow-up schedule 15. Legal incapacity or limited legal capacity

Design outcomes

Primary

Measure	Time frame
Secondary Objective: · Overall Survival · Progression free survival · Secondary resection · Early tumor shrinkage (ETS) · Depth of response (DpR) · Safety profile (NCI CTCAE v 4.03 classification) · Diagnostic performance of ccfDNA analysis compared to the tumor-tissue analysis (current gold standard);Main Objective: Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.;Primary end point(s): Complete response rate where complete response is defined as complete disappearance of metastatic lesions after a maximum of 12 cycles of chemotherapy and tumor marker level normalization (CEA).;Timepoint(s) of evaluation of this end point: _	—

Measure

Time frame

Secondary Objective: · Overall Survival · Progression free survival · Secondary resection · Early tumor shrinkage (ETS) · Depth of response (DpR) · Safety profile (NCI CTCAE v 4.03 classification) · Diagnostic performance of ccfDNA analysis compared to the tumor-tissue analysis (current gold standard);Main Objective: Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.;Primary end point(s): Complete response rate where complete response is defined as complete disappearance of metastatic lesions after a maximum of 12 cycles of chemotherapy and tumor marker level normalization (CEA).;Timepoint(s) of evaluation of this end point: _

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Secondary

Measure	Time frame
Secondary end point(s): • 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);Timepoint(s) of evaluation of this end point: _	—

Measure

Time frame

Secondary end point(s): • 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);Timepoint(s) of evaluation of this end point: _

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Countries

France

Contacts

Public ContactSandra PELISSIER

UNICANCER

s-pelissier@unicancer.fr+33144 23 55 68

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026

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