Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer
CHARTA
FOLFOX and Bevacizumab With or Without Irinotecan in First-line Treatment for Metastatic Colorectal Cancer. A Randomized Phase II Study
1 other identifier
interventional
250
1 country
51
Brief Summary
The primary objective of this study is to evaluate the efficacy of Irinotecan in combination with FOLFOX+Bevacizumab versus FOLFOX+Bevacizumab alone in the first-line treatment of patients with metastatic colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Longer than P75 for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2011
CompletedFirst Posted
Study publicly available on registry
March 24, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2018
CompletedOctober 25, 2018
October 1, 2018
5.3 years
March 23, 2011
October 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
progression free survival rate
9 months after first study drug administration
Secondary Outcomes (6)
tumour response according to RECIST v 1.1
until progression of disease for a maximum of two years after end of treatment
Secondary resection rate
for a maximum of two years after end of treatment
Progression free survival rate
until progression of disease for a maximum of two years after end of treatment
Overall survival
until death for a maximum of two years after end of treatment
Adverse events
18 months after the date of last study drug administration
- +1 more secondary outcomes
Study Arms (2)
FOLFOX+Bevacizumab
ACTIVE COMPARATORbevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
FOLFOX+Bevacizumab+Irinotecan
EXPERIMENTALbevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) irinotecan at a dose of 165 mg/m2 iv over two hours (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
Interventions
bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) irinotecan at a dose of 165 mg/m2 iv over two hours (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
Eligibility Criteria
You may qualify if:
- Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
- Patients with at least one measurable lesion, with size \> 1 cm (RECIST v1.1)
- ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
- Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
- Life expectancy \> 3 months
- Age ≥ 18 years
- Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
- g/dl or 5.59 mmol/l
- Patients not receiving therapeutic anticoagulation must have an INR \< 1.5 ULN and aPTT \< 1.5 ULN within 7 days prior to registration. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of registration.
- Adequate liver function as measured by serum transaminases (AST \& ALT) ≤ 2.5 x ULN (in case of liver metastases \< 5 x ULN) and total bilirubin ≤ 1.5 x ULN
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN
- Signed, written informed consent
You may not qualify if:
- Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
- Patients with at least one measurable lesion, with size \> 1 cm (RECIST v1.1)
- ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
- Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
- Life expectancy \> 3 months
- Age ≥ 18 years
- Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
- g/dl or 5.59 mmol/l
- Patients not receiving therapeutic anticoagulation must have an INR \< 1.5 ULN and aPTT \< 1.5 ULN within 7 days prior to registration. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of registration.
- Adequate liver function as measured by serum transaminases (AST \& ALT) ≤ 2.5 x ULN (in case of liver metastases \< 5 x ULN) and total bilirubin ≤ 1.5 x ULN
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN
- Signed, written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Martin-Luther-Universität Halle-Wittenberglead
- Roche Pharma AGcollaborator
Study Sites (51)
Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
Berlin, Germany
Knappschaftskrankenhaus Bottrop
Bottrop, Germany
Onkologische Praxis
Bottrop, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Cologne, Germany
Studiengesellschaft Kátay + Reiser GbR
Cologne, Germany
Städtisches Klinikum Dessau
Dessau, Germany
Evangelisches Krankenhhaus Dinslaken
Dinslaken, Germany
Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, Germany
Onkozenrum Dresden
Dresden, Germany
Onkologie Duisburg
Duisburg, Germany
St. Georg Klinikum Eisenach gGmbH
Eisenach, Germany
Katholisches Krankenhaus St. Johann Nepomuk
Erfurt, Germany
pioh Praxis
Frechen, Germany
Partnerschaft FÄ für Innere Medizin
Freiberg, Germany
MVZ Osthessen GmbH
Fulda, Germany
Kreiskrankenhaus Gummersbach GmbH
Gummersbach, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, 06097, Germany
Marienkrankenhaus Hamburg
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Überörtliche Gemeinschaftspraxis für Innere Medizin
Hamburg, Germany
Klinikum Region Hannover GmbH,
Hanover, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Praxis Dr. Schröder
Hanover, Germany
Klinikum Heidenheim
Heidenheim, Germany
SP Hämatologie u. Internistische Onkologie
Hennigsdorf, Germany
Onkologische Schwerpunktpraxis im Medicinum
Hildesheim, Germany
St. Bernward Krankenhaus
Hildesheim, Germany
Sanaklinikum Hof GmbH
Hof, Germany
Institut für med. Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung GbR
Kaiserslautern, Germany
St. Cincentius-Kliniken gAG
Karlsruhe, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Praxis für Innere Medizin und Gastroenterologie
Köthen, Germany
Praxis für Innere Medizin
Laatzen, Germany
Ortenau Klinikum - Lahr Ettenhaim
Lahr, Germany
Gemeinschaftspraxis Dr. med. Veling-Kaiser
Landshut, Germany
Medizinisches Versorgungszentrum Mitte
Leipzig, Germany
Onco Studies Lörrach-OSL an der Schwerpunktpraxis Onkologie Dreiländereck
Loerrach, Germany
Klinikum Magdeburg gGmbH
Magdeburg, Germany
Universitätsklinikum Magdeburg
Magdeburg, Germany
Internistisches Fachzentrum mit Dialyse, Onkologische Praxis am Klinikum
Memmingen, Germany
Friedrich-Ebert-Krankenhaus Neumünster GmbH
Neumünster, Germany
PIUS-Hospital Oldenburg
Oldenburg, Germany
Universitätsklinikum Rostock
Rostock, Germany
MedResearch - Medizinisches Studien- u. Dokumentationszentrum Leipziger Land
Rötha, Germany
Praxis für Innere Medizin, Hämatololgie und Onkologie
Schkeuditz, Germany
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
Schweinfurt, Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH
Trier, Germany
Praxisnetzwerk Hämaologie/Intern. Onkologie
Troisdorf, Germany
Ammerland-Klinik GmbH
Westerstede, Germany
Praxisgemeinschaft für Onkologie und Urologie Wilhelmshaven
Wilhelmshaven, Germany
Praxis Dr. med. Mathias Schulze
Zittau, Germany
Related Publications (3)
Schmoll HJ, Mann J, Meinert F, Garlipp B, Borchert K, Vogel A, Goekkurt E, Kaiser U, Hoeffkes HG, Russel J, Kanzler S, Edelmann T, Forstbauer H, Gohler T, Hannig C, Hildebrandt B, Roll C, Bokemeyer C, Steighardt J, Cygon F, Ibach S, Stein A, Tintelnot J. Efficacy and quality of life for FOLFOX/bevacizumab +/- irinotecan in first-line metastatic colorectal cancer-final results of the AIO CHARTA trial. Br J Cancer. 2024 Feb;130(2):233-241. doi: 10.1038/s41416-023-02496-4. Epub 2023 Nov 23.
PMID: 37996507DERIVEDCremolini C, Antoniotti C, Stein A, Bendell J, Gruenberger T, Rossini D, Masi G, Ongaro E, Hurwitz H, Falcone A, Schmoll HJ, Di Maio M. Individual Patient Data Meta-Analysis of FOLFOXIRI Plus Bevacizumab Versus Doublets Plus Bevacizumab as Initial Therapy of Unresectable Metastatic Colorectal Cancer. J Clin Oncol. 2020 Aug 20:JCO2001225. doi: 10.1200/JCO.20.01225. Online ahead of print.
PMID: 32816630DERIVEDStein A, Glockzin G, Wienke A, Arnold D, Edelmann T, Hildebrandt B, Hollerbach S, Illerhaus G, Konigsrainer A, Richter M, Schlitt HJ, Schmoll HJ. Treatment with bevacizumab and FOLFOXIRI in patients with advanced colorectal cancer: presentation of two novel trials (CHARTA and PERIMAX) and review of the literature. BMC Cancer. 2012 Aug 16;12:356. doi: 10.1186/1471-2407-12-356.
PMID: 22897915DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans-Joachim Schmoll, MD
Universitätsklinikum Halle
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 23, 2011
First Posted
March 24, 2011
Study Start
May 1, 2011
Primary Completion
September 1, 2016
Study Completion
August 15, 2018
Last Updated
October 25, 2018
Record last verified: 2018-10