Metastatic Colorectal CancerPhase 2PANIRINOXNCT02980510
Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients
A Phase 2 study testing Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil and Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan in people with Metastatic Colorectal Cancer, run by UNICANCER at 6 sites in France.
Trial summary
National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis. Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil and Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 6 sitesFrance
- Study dates
- Dec 2016to Jan 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- ECOG PS between 0 and 1
- Histologically confirmed adenocarcinoma of the colon or rectum
- Untreated synchronous or metachronous metastatic disease deemed unresectable with curative intent
- 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
- Measurable disease according to RECIST version 1.1
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- Adequate hematologic, hepatic and renal functions:
- Absolute neutrophil count (ANC) ≥2 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)
- Life expectancy of at least 3 months
- Adequate contraception if applicable
- Patient affiliated to a social security regimen
- Patient information and signed written consent form
- Uracilemia < 16 ng/ml
Who cannot join
- History of other malignancy within the previous 5 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
- Adjuvant treatment with oxaliplatin
- Previous treatment for metastatic disease
- Patients who received any chemo- and/or radiotherapy within 15 days from the date of blood sampling for the RAS and BRAF test
- Brain metastases
- Patients with a history of severe or life-threatening hypersensitivity to the active substances or to any of the excipients delivered in this study
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- Patient with history of pulmonary fibrosis or interstitial pneumonitis
- Previous organ transplantation, HIV or other immunodeficiency syndromes
- Concomitant medications/comorbidities that may prevent the patient from receiving study treatment as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, inflammatory bowel disease, intestinal obstruction, symptomatic congestive heart failure, uncontrolled hypertension…)
- Persistent peripheral neuropathy >grade1 (NCI CT v4.03)
- Ionic disorders as:
- Kalemia ≤1 x LLN
- Magnesemia <0.5mmol/L
- Calcemia <2mmol/L
- Patient with known dihydropyrimidine dehydrogenase deficiency
- QT/QTc>450msec for men and >470msec for women
- Patient with contraindication for trial drugs (investigators have to refer to SmPC drugs, see Appendix 7)
- Concomitant intake of St. John's wort
- Other concomitant cancer
- Participation in another therapeutic trial
- Pregnant woman or lactating woman
- Patients with psychological, familial, sociological or geographical condition hampering compliance with the study protocol and follow-up schedule
- Legal incapacity or limited legal capacity
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Institut Sainte Catherine
Avignon
Centre Léon Berard
Lyon
Chu Saint Eloi
Montpellier
ICM Val D'Aurelle
Montpellier
Institut de Cancérologie de Lorraine
Nancy
CHU Carémeau - Institut de Cancérologie du Gard
Nîmes
About this study
Official title: 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
National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis.
Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.
Read the detailed description
PRIMARY OBJECTIVE: Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab
SECONDARY OBJECTIVE(S):
- Overall Survival
- Progression free survival
- Secondary resection
- Early tumor shrinkage (ETS)
- Depth of response (DpR)
- Safety profile (NCI-CTCAE v4.03 classification)
- Diagnostic performance of ccfDNA analysis compared to the tumor-tissue analysis (current gold standard)
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab, oxaliplatin, folinic acid, 5-fluoruracilDrug
Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecanDrug
| Study group | Role | What they receive |
|---|---|---|
| A=Experimental group | Experimental | FOLFIRINOX + Panitumumab oxaliplatin 85 mg/m² IV infusion over 2 hours immediately followed by folinic acid 400 mg/m² given as a 2-hour intravenous (IV) infusion with the addition, after 30 minutes of irinotecan 150 mg/m² given as a 90-minute intravenous infusion through a Y-connector immediately followed by fluorouracil 400 mg/m² IV bolus then 5-fluoruracil (5-FU) 2400 mg/m² over 46 hours continuous infusion. Receives: Drug: Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan |
| B=Control group | Active comparator | mFOLFOX6 + Panitumumab mFOLFOX6 every 2 weeks: oxaliplatin 85 mg/m² IV infusion over 2 hours immediately followed by folinic acid 400 mg/m² IV infusion over 2 hours followed by fluorouracil 400 mg/m² IV bolus then 5-FU 2400 mg/m² over 46 hours continuous infusion. Receives: Drug: Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2025
- Study completionJan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis.
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault MAZARD, Principal investigator, ICM VAL D'AURELLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980510
- Sponsor's protocol ID
- UCGI 28 PANIRINOX
- Other IDs
- 2016-001490-33, 2016
- Acronym
- PANIRINOX
- Status last verified
- Aug 2026
- First submitted
- 30 Nov 2016
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Publications
Pisareva E, Mihalovicova L, Pastor B, Kudriavtsev A, Mirandola A, Mazard T, Badiou S, Maus U, Ostermann L, Weinmann-Menke J, Neuberger EWI, Simon P, Thierry AR. Neutrophil extracellular traps have auto-catabolic activity and produce mononucleosome-associated circulating DNA. Genome Med. 2022 Nov 28;14(1):135. doi: 10.1186/s13073-022-01125-8.
PubMed 36443816