Evidence map›Paper›PMID 23391248›Full record

Trial reportBMC cancer2013

A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: the COMBATAC trial.

Gabriel Glockzin, Justine Rochon, Dirk Arnold, Sven A Lang, Frank Klebl, Florian Zeman, Michael Koller, Hans J Schlitt, Pompiliu Piso

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01540344 (Multimodality Treatment Including Pre- and Postoperative Systemic Chemotherapy Plus Cetuximab, Cytoreductive Surgery), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
7.8field-weighted citation impact, top 2% 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.

NCT01540344 phase2terminatednot on this map

Multimodality Treatment Including Pre- and Postoperative Systemic Chemotherapy Plus Cetuximab, Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis Arising From Wild Type K-ras Colon Cancer: A Prospective Multicenter Phase II Study.

TypeinterventionalSponsorUniversity of RegensburgRan2010 to 2017Enrolled26ConditionsPeritoneal Carcinomatosis, Colorectal Cancer MetastaticArmsCRS, HIPEC
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 44 citations in OpenAlex.

  1. Trial
  2. Review
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  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Therapeutic options for peritoneal metastasis arising from colorectal cancer.World journal of gastrointestinal pharmacology and therapeutics · 2016
    Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. [Cytoreductive surgery for malignant peritoneal tumors].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2015
    Review
  15. Article
  16. Article
  17. Article
  18. 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

9 authors at 3 institutions in 1 country.

Gabriel GlockzinDepartment of Surgery, University Medical Center Regensburg, Regensburg 93042, Germany. gabriel.glockzin@ukr.de
Justine Rochon
Dirk Arnold
Sven A Lang
Frank Klebl
Florian Zeman
Michael Koller
Hans J Schlitt
Pompiliu Piso
University Hospital Regensburg · DEHeidelberg University · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeritoneal carcinomatosis is regarded as a common sign of advanced tumor stage, tumor progression or local recurrence of appendiceal and colorectal cancer and is generally associated with poor prognosis. Although survival of patients with advanced stage CRC has markedly improved over the last 20 years with systemic treatment, comprising combination chemotherapy +/- monoclonal antibodies, the oncological outcome-especially of the subgroup of patients with peritoneal metastases-is still unsatisfactory. In addition to systemic therapy, cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are specific treatment options for a selected group of these patients and may provide an additional therapeutic benefit in the framework of an interdisciplinary treatment concept. METHODS/

designThe COMBATAC trial is a prospective, multicenter, open-label, single-arm, single-stage phase II trial investigating perioperative systemic polychemotherapy including cetuximab in combination with CRS and HIPEC patients with histologically proven wild-type KRAS colorectal or appendiceal adenocarcinoma and synchronous or metachronous peritoneal carcinomatosis. The planned total number of patients to be recruited is 60. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), perioperative morbidity and treatment-associated toxicity, feasibility of the combined treatment regimen, quality of life (QoL) and histopathological regression after preoperative chemotherapy. DISCUSSION: The COMBATAC trial is designed to evaluate the feasibility and efficacy of the combined multidisciplinary treatment regimen consisting of perioperative systemic combination chemotherapy plus cetuximab and CRS plus bidirectional HIPEC with intraperitoneal oxaliplatin.

trial registrationClinicalTrials.gov Identifier: NCT01540344, EudraCT number: 2009-014040-11.

Indexed as

Chemotherapy, Cancer, Regional PerfusionDigestive System Surgical ProceduresHypothermia, InducedMetastasectomyResearch DesignAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsAppendiceal NeoplasmsChemotherapy, AdjuvantColorectal NeoplasmsDisease-Free SurvivalFeasibility StudiesGermanyHumansPeritoneal NeoplasmsProspective StudiesKRAS protein, humanProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)ras Proteins

Identifiers

PMID23391248
PMCPMC3575316
OpenAlexW2130585977

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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.