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Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients

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

NCT02980510•UNICANCER

View on ClinicalTrials.gov

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.

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)

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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) ≥2 x 109/L
•* Haemoglobin ≥9 g/dL
•* Platelets (PTL) ≥100 x 109/L
+9 more 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, inflammatory bowel disease, intestinal obstruction, symptomatic congestive heart failure, uncontrolled hypertension…)
•10. Persistent peripheral neuropathy \>grade1 (NCI CT v4.03)
+13 more criteria

Locations (6)

Institut Sainte Catherine

Avignon, France

Centre Léon Berard

Lyon, France

Chu Saint Eloi

Montpellier, France

ICM Val D'Aurelle

Montpellier, France

Institut de Cancérologie de Lorraine

Nancy, France

CHU Carémeau - Institut de Cancérologie du Gard

Nîmes, France

Key Dates

Start Date

December 1, 2016

Primary Completion Date

December 1, 2025

Completion Date

January 1, 2026

Last Updated

February 20, 2025

Enrollment

219

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil

DRUG

Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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