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Metastatic Colorectal CancerPhase 2CHARTANCT01321957

Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer

A Phase 2 study testing Oxaliplatin, 5FU/LV, Bevacizumab and 5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan in people with Metastatic Colorectal Cancer, run by Martin-Luther-Universität Halle-Wittenberg at 51 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Oxaliplatin, 5FU/LV, Bevacizumab and 5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
51 sitesGermany
Study dates
May 2011to 15 Aug 2018
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
  • 9 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

Who cannot join

  • 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
Show all 12Show fewer
  • Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
  • 9 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

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

Germany51 sites

  • Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie

    Berlin

  • Knappschaftskrankenhaus Bottrop

    Bottrop

  • Onkologische Praxis

    Bottrop

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Cologne

  • Studiengesellschaft Kátay + Reiser GbR

    Cologne

  • Städtisches Klinikum Dessau

    Dessau

  • Evangelisches Krankenhhaus Dinslaken

    Dinslaken

  • Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden

  • Onkozenrum Dresden

    Dresden

  • Onkologie Duisburg

    Duisburg

  • St. Georg Klinikum Eisenach gGmbH

    Eisenach

  • Katholisches Krankenhaus St. Johann Nepomuk

    Erfurt

  • pioh Praxis

    Frechen

  • Partnerschaft FÄ für Innere Medizin

    Freiberg

  • MVZ Osthessen GmbH

    Fulda

  • Kreiskrankenhaus Gummersbach GmbH

    Gummersbach

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06097

  • Marienkrankenhaus Hamburg

    Hamburg

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Überörtliche Gemeinschaftspraxis für Innere Medizin

    Hamburg

  • Klinikum Region Hannover GmbH,

    Hanover

  • Medizinische Hochschule Hannover

    Hanover

  • Praxis Dr. Schröder

    Hanover

  • Klinikum Heidenheim

    Heidenheim

  • SP Hämatologie u. Internistische Onkologie

    Hennigsdorf

  • Onkologische Schwerpunktpraxis im Medicinum

    Hildesheim

  • St. Bernward Krankenhaus

    Hildesheim

  • Sanaklinikum Hof GmbH

    Hof

  • Institut für med. Dokumentation, Gutachtenerstellung, Gesundheitsförderung u. Qualitätssicherung GbR

    Kaiserslautern

  • St. Cincentius-Kliniken gAG

    Karlsruhe

  • Universitätsklinikum Schleswig-Holstein

    Kiel

  • Praxis für Innere Medizin und Gastroenterologie

    Köthen

  • Praxis für Innere Medizin

    Laatzen

  • Ortenau Klinikum - Lahr Ettenhaim

    Lahr

  • Gemeinschaftspraxis Dr. med. Veling-Kaiser

    Landshut

  • Medizinisches Versorgungszentrum Mitte

    Leipzig

  • Onco Studies Lörrach-OSL an der Schwerpunktpraxis Onkologie Dreiländereck

    Loerrach

  • Klinikum Magdeburg gGmbH

    Magdeburg

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Internistisches Fachzentrum mit Dialyse, Onkologische Praxis am Klinikum

    Memmingen

  • Friedrich-Ebert-Krankenhaus Neumünster GmbH

    Neumünster

  • PIUS-Hospital Oldenburg

    Oldenburg

  • Universitätsklinikum Rostock

    Rostock

  • MedResearch - Medizinisches Studien- u. Dokumentationszentrum Leipziger Land

    Rötha

  • Praxis für Innere Medizin, Hämatololgie und Onkologie

    Schkeuditz

  • Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

    Schweinfurt

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier

  • Praxisnetzwerk Hämaologie/Intern. Onkologie

    Troisdorf

  • Ammerland-Klinik GmbH

    Westerstede

  • Praxisgemeinschaft für Onkologie und Urologie Wilhelmshaven

    Wilhelmshaven

  • Praxis Dr. med. Mathias Schulze

    Zittau

Other trials in Germany

About this study

Official title: FOLFOX and Bevacizumab With or Without Irinotecan in First-line Treatment for Metastatic Colorectal Cancer. A Randomized Phase II Study

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.

Read the detailed description

5-Fluorouracil and oxaliplatin (FOLFOX-Regimen) in combination with bevacizumab is regarded as standard first-line treatment in metastatic colorectal cancer [Saltz et al., 2008]. Current studies established the role of the FOLFOXIRI regimen [Souglakos et al., 2006, Falcone et al., 2007]. A further intensification of the therapy seems feasible yielding response rates up to 84% and a disease control rate up to 100% [Falcone, 2008, Santomaggio, 2009, Masi, 2010]. This trial evaluates the activity of an intensified first-line therapy for metastatic colorectal cancer compared to standard treatment.

Being tested
Oxaliplatin, 5FU/LV, Bevacizumab, 5FU/LV, Oxaliplatin, Bevacizumab, 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.

  • Oxaliplatin, 5FU/LV, BevacizumabDrug

    Also called Bevacizumab, Oxaliplatin, I-LV, 5-FU

    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)

  • 5FU/LV, Oxaliplatin, Bevacizumab, IrinotecanDrug

    Also called Bevacizumab, Oxaliplatin, I-LV, 5-FU

    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)

Study groups in NCT01321957
Study groupRoleWhat they receive
FOLFOX+BevacizumabActive 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)
Receives: Drug: Oxaliplatin, 5FU/LV, Bevacizumab
FOLFOX+Bevacizumab+IrinotecanExperimentalbevacizumab 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)
Receives: Drug: 5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival rate

    Measured: 9 months after first study drug administration

Secondary outcomes (6)

  1. tumour response according to RECIST v 1.1

    Measured: until progression of disease for a maximum of two years after end of treatment

  2. Secondary resection rate

    Measured: for a maximum of two years after end of treatment

  3. Progression free survival rate

    Measured: until progression of disease for a maximum of two years after end of treatment

  4. Overall survival

    Measured: until death for a maximum of two years after end of treatment

  5. Adverse events

    Toxicity of study medication

    Measured: 18 months after the date of last study drug administration

  6. Quality of Life evaluated by questionnaire

    Quality of Life evaluated using questionnaire EORTC QLQ-30

    Measured: Until end of treatment (maximum 2 years after first study drug administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionSep 2016
  4. Study completion15 Aug 2018

Resources

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
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01321957
Sponsor's protocol ID
AIO-0209
Acronym
CHARTA
Status last verified
Oct 2018
First submitted
23 Mar 2011
Last updated
25 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37996507

  • Cremolini 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.

    PubMed 32816630

  • Stein 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.

    PubMed 22897915

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, 5FU/LV, Bevacizumab and 5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan in people with Metastatic Colorectal Cancer, run by Martin-Luther-Universität Halle-Wittenberg at 51 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival rate (time frame: 9 months after first study drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01321957, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.

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