Evidence map›Paper›PMID 29644408›Full record

Trial reportJournal of cancer research and clinical oncology2018

MODUL-a multicenter randomized clinical trial of biomarker-driven maintenance therapy following first-line standard induction treatment of metastatic colorectal cancer: an adaptable signal-seeking approach.

Hans-Joachim Schmoll, Dirk Arnold, Aimery de Gramont, Michel Ducreux, Axel Grothey, Peter J O'Dwyer, Eric Van Cutsem, Frank Hermann, Ivan Bosanac, Belguendouz Bendahmane and 2 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Circulating Tumor DNA to Drive Treatment in Metastatic Colorectal Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Review
  6. Current status and prospect of immunotherapy for colorectal cancer.International journal of colorectal disease · 2023
    Review
  7. Review
  8. Review
  9. Therapeutic landscape and future direction of metastatic colorectal cancer.Nature reviews. Gastroenterology & hepatology · 2023
    Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
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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.

Hans-Joachim SchmollDivision of Clinical Oncology Research, University Clinic Halle (Saale), Martin-Luther-University Halle-Wittenberg, Ernst-Grube-Str. 40, 06120, Halle, Germany. hans-joachim.schmoll@uk-halle.de.ORCID http://orcid.org/0000-0001-8705-0593
Dirk ArnoldInstituto CUF de Oncologia, Lisbon, Portugal.
Aimery de GramontHôpital Saint Antoine, Paris, France.
Michel DucreuxGustave Roussy, Villejuif, Université Paris Saclay, Paris, France.
Axel GrotheyMayo Clinic College of Medicine, Rochester, MN, USA.
Peter J O'DwyerAbramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
Eric Van CutsemUniversity Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, Belgium.
Frank HermannMolecular Partners, Zurich (previously F. Hoffmann-La Roche Ltd), Basel, Switzerland.
Ivan BosanacF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Belguendouz BendahmaneF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Christoph MancaoGenentech Inc., Basel, Switzerland.
Josep TaberneroVall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe old approach of one therapeutic for all patients with mCRC is evolving with a need to target specific molecular aberrations or cell-signalling pathways. Molecular screening approaches and new biomarkers are required to fully characterize tumours, identify patients most likely to benefit, and predict treatment response.

methodsMODUL is a signal-seeking trial with a design that is highly adaptable, permitting modification of different treatment cohorts and inclusion of further additional cohorts based on novel evidence on new compounds/combinations that emerge during the study.

resultsMODUL is ongoing and its adaptable nature permits timely and efficient recruitment of patients into the most appropriate cohort. Recruitment will take place over approximately 5 years in Europe, Asia, Africa, and South America. The design of MODUL with ongoing parallel/sequential treatment cohorts means that the overall size and duration of the trial can be modified/prolonged based on accumulation of new data.

conclusionsThe early success of the current trial suggests that the design may provide definitive leads in a patient-friendly and relatively economical trial structure. Along with other biomarker-driven trials that are currently underway, it is hoped that MODUL will contribute to the continuing evolution of clinical trial design and permit a more 'tailored' approach to the treatment of patients with mCRC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCohort StudiesColorectal NeoplasmsEndpoint DeterminationErb-b2 Receptor Tyrosine KinasesHumansInduction ChemotherapyMaintenance ChemotherapyProto-Oncogene Proteins B-rafBiomarkers, TumorBRAF protein, humanERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesProto-Oncogene Proteins B-rafBiomarkerFOLFOX + bevacizumabMetastatic colorectal cancerMODULSignal seekingSwitch maintenance therapy

Identifiers

PMID29644408
PMCPMC11813285

What OpenQuestion holds

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Registered trials

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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.