Evidence map›Paper›PMID 22897915›Full record

Trial reportBMC cancer2012

Treatment with bevacizumab and FOLFOXIRI in patients with advanced colorectal cancer: presentation of two novel trials (CHARTA and PERIMAX) and review of the literature.

Alexander Stein, Gabriel Glockzin, Andreas Wienke, Dirk Arnold, Thomas Edelmann, Bert Hildebrandt, Stephan Hollerbach, Gerald Illerhaus, Alfred Königsrainer, Michael Richter and 2 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialReview
In one paragraph

Trial report in BMC cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01321957 phase2completednot on this map

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

TypeinterventionalSponsorMartin-Luther-Universität Halle-WittenbergRan2011 to 2018Enrolled250ConditionsMetastatic Colorectal CancerArmsOxaliplatin, 5FU/LV, Bevacizumab, 5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan
NCT01540435 phase2withdrawnnot on this map

Perioperative FOLFOXIRI and Bevacizumab Compared With Postoperative FOLFOX in Patients With Resectable Liver Metastases From Colorectal Cancer (PERIMAX). A Randomized, Multidisciplinary DGAV(CAO-V/CALGP)/AIO Phase II Trial

TypeinterventionalSponsorUniversity of RegensburgRan2012 to 2013Enrolled0ConditionsColon Cancer Liver MetastasisArmsBevacizumab
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. What is the optimal neo-adjuvant treatment for liver metastasis?Therapeutic advances in medical oncology · 2013
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Alexander SteinUniversity Cancer Center Hamburg, Germany.
Gabriel Glockzin
Andreas Wienke
Dirk Arnold
Thomas Edelmann
Bert Hildebrandt
Stephan Hollerbach
Gerald Illerhaus
Alfred Königsrainer
Michael Richter
Hans J Schlitt
Hans-Joachim Schmoll
Martin Luther University Halle-Wittenberg · DECharité - Universitätsmedizin Berlin · DEInstitute of Pathology Celle · DEUniversität Hamburg · DEUniversity Cancer Center Hamburg · DEUniversity Children's Hospital Tübingen · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMore than half of patients with colorectal cancer will develop metastatic disease either evident at the time of initial diagnosis or during their course of disease. Besides multidisciplinary management further treatment intensification is warranted to improve the still limited prognosis. METHODS/

designIn these two multi-centre, randomized phase II trials, conducted in Germany, 380 patients with R0-resectable colorectal liver metastases (PERIMAX) and with unresectable, metastatic colorectal cancer (CHARTA) will be recruited. Patients previously untreated for metastatic disease with either synchronous or metachronous metastases are randomly assigned in a 1:1 ratio to resection of colorectal liver metastases followed by postoperative FOLFOX for 6 months or perioperative FOLFOXIRI and bevacizumab for 3 months pre- and postoperative and resection (PERIMAX), or to induction chemotherapy with FOLFOX and bevacizumab +/- irinotecan for a maximum of 6 months followed by maintenance treatment with fluoropyrimidine and bevacizumab. The primary objective of these trials is to evaluate the feasibility and efficacy of FOLFOXIRI and bevacizumab in metastatic colorectal cancer. Primary endpoint is failure free survival rate at 18 months in the PERIMAX trial and progression free survival rate at 9 months in CHARTA. Secondary objectives include efficacy, safety and tolerability. DISCUSSION: The CHARTA and PERIMAX trials are designed to evaluate the benefits and limitations of a highly active four-drug regimen in distinct treatment situations of metastatic CRC. Eligible patients are classified into resectable liver metastases to be randomized to perioperative treatment with FOLFOXIRI and bevacizumab or postoperative FOLFOX in the PERIMAX, or unresectable metastatic CRC to be randomized between FOLFOX and bevacizumab with or without irinotecan, stratified for clinical groups according to disease and patients' characteristics in the CHARTA trial.

trial registrationClinical trial identifier CHARTA: NCT01321957, PERIMAX: NCT01540435.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinColorectal NeoplasmsCombined Modality TherapyDisease-Free SurvivalFluorouracilHumansIrinotecanLeucovorinLiver NeoplasmsMulticenter Studies as TopicOrganoplatinum CompoundsRandomized Controlled Trials as TopicAntibodies, Monoclonal, HumanizedBevacizumabCamptothecinFluorouracilIrinotecanLeucovorinOrganoplatinum Compounds

Identifiers

PMID22897915
PMCPMC3503684
OpenAlexW2070222840

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.