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COMPLETEDPHASE2

FOLFOXIRI With or Without Panitumumab in Metastatic Colorectal Cancer (VOLFI)

An Open-label 2:1 Randomized Phase II Study of Panitumumab Plus FOLFOXIRI or FOLFOXIRI Alone as First-line Treatment of Patients With Non-resectable Metastatic Colorectal Cancer and RAS Wild Type

NCT01328171•AIO-Studien-gGmbH

View on ClinicalTrials.gov

Summary

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer of RAS wildtype. The patients will be treated in two therapy groups: Experimental arm A: Chemotherapy with FOLFOXIRI + panitumumab Standard arm B: Chemotherapy with FOLFOXIRI

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cohort I: Histologically confirmed and definitively inoperable or irresectable metastatic colorectal cancer. Focus on patients with large tumor load at metastatic sites and/or symptomatic metastatic disease
•Cohort II: Chance of secondary resection with curative intent defined and reviewed by expert panel
•Adult patients (≥ 18 years of age)
•RAS wild-type tested in
•* KRAS exon 2 (codons 12/13)
•* KRAS exon 3 (codons 59/61)
•* KRAS exon 4 (codons 117/146)
•* NRAS exon 2 (codons 12/13)
•* NRAS exon 3 (codons 59/61)
•* NRAS exon 4 (codons 117/146) assessed by an institution participating in and certified by the specific working group of the Deutsche Gesellschaft für Pathologie)
+8 more criteria

Exclusion Criteria

•Past or current history of malignancies except for the indication under this study and curatively treated:
•Basal and squamous cell carcinoma of the skin
•In-situ carcinoma of the cervix
•Other malignant disease without recurrence after at least 5 years of follow-up
•Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment.
•Clinically relevant interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
•History of evidence upon physical examination of CNS disease unless adequately treated (e.g. primary brain tumour, seizure not controlled with standard medical therapy, brain metastases or history of stroke).
•Pre-existing neuropathy \> grade 1 (NCI CTCAE), except for loss of tendon reflex
•Allogeneic transplantation requiring immunosuppressive therapy.
•Severe non-healing wounds, ulcers or bone fractions.
+10 more criteria

Locations (19)

Klinikum Esslingen

Esslingen am Neckar, Baden-Wurttemberg, Germany

SLK-Kliniken Heilbronn GmbH

Heilbronn, Baden-Wurttemberg, Germany

Ortenau Klinikum

Lahr, Baden-Wurttemberg, Germany

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, Germany

Universitätsklinikum Mannheim

Mannheim, Baden-Wurttemberg, Germany

Klinikum Schwäbisch Gmünd

Mutlangen, Baden-Wurttemberg, Germany

Kreiskliniken Esslingen gGmbH Klinik Nürtingen

Nürtingen, Baden-Wurttemberg, Germany

Schwerpunktpraxis und Tagesklinik Onkologie Hämatologie Gastroenterologie Palliativmedizin Drs. Höring, Respondek, Schwinger, Thunert

Stuttgart, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm Zentrum für Innere Medizin

Ulm, Baden-Wurttemberg, Germany

Klinikum Augsburg

Augsburg, Bavaria, Germany

Key Dates

Start Date

April 1, 2011

Primary Completion Date

June 1, 2017

Completion Date

January 1, 2022

Last Updated

June 15, 2023

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

FOLFOXIRI + Panitumumab

DRUG

FOLFOXIRI

DRUG

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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: June 15, 2023Data 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.

View ClinicalTrials.gov Terms and Conditions

FOLFOXIRI With or Without Panitumumab in Metastatic Colorectal Cancer (VOLFI)

Inclusion Criteria

Exclusion Criteria

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

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

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease

A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer

A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer