Evidence map›Paper›PMID 31150315›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12.

Emmanouil Fokas, Michael Allgäuer, Bülent Polat, Gunther Klautke, Gerhard G Grabenbauer, Rainer Fietkau, Thomas Kuhnt, Ludger Staib, Thomas Brunner, Anca-Ligia Grosu and 16 more

Registry-linked trialAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05054959 (Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Locally Advanced Rectal Cancer With High Risk of Recurrence), which is not on this map. Cited by 293 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
293citing papers in PubMed, 5 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.

NCT05054959 phase2active not recruitingnot on this mapstarted 2021, after this paper: background citation

Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Locally Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)

TypeinterventionalSponsorInstitute of Oncology LjubljanaRan2021 to 2028Enrolled62ConditionsLocally Advanced Rectal CancerArmsConsolidation CAPOX Chemotherapy, Induction CAPOX Chemotherapy
3 · Its place in the literature

Who cites it

293 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  18. Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
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233 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Emmanouil FokasUniversity of Frankfurt, Frankfurt, Germany.
Michael AllgäuerBarmherzige Brüder Hospital Regensburg, Regensburg, Germany.
Bülent PolatUniversity Hospital of Würzburg, Würzburg, Germany.
Gunther KlautkePoliklinik Chemnitz, Chemnitz, Germany.
Gerhard G GrabenbauerDiaCura, Klinikum Coburg, Coburg, Germany.
Rainer FietkauUniversity of Erlangen-Nürnberg, Erlangen, Germany.
Thomas KuhntUniversity of Leipzig, Leipzig, Germany.
Ludger StaibKlinikum Esslingen, Esslingen, Germany.
Thomas BrunnerUniversity of Freiburg, Freiburg, Germany.
Anca-Ligia GrosuUniversity of Freiburg, Freiburg, Germany.
Wolff SchmiegelRuhr-University Bochum, Bochum, Germany.
Lutz JacobaschPraxis of Haematology and Oncology, Dresden, Germany.
Jürgen WeitzGerman Cancer Research Center, Heidelberg, Germany.
Gunnar FolprechtGerman Cancer Research Center, Heidelberg, Germany.
Anke Schlenska-LangeGerman Cancer Research Center, Heidelberg, Germany.
Michael FlentjeUniversity Hospital of Würzburg, Würzburg, Germany.
Christoph-Thomas GermerUniversity Hospital of Würzburg, Würzburg, Germany.
Robert GrützmannUniversity of Erlangen-Nürnberg, Erlangen, Germany.
Matthias SchwarzbachKlinikum Frankfurt Höchst, Frankfurt, Germany.
Vittorio PaolucciKetteler Krankenhaus, Offenbach, Germany.
Wolf O BechsteinUniversity of Frankfurt, Frankfurt, Germany.
Tim FriedeUniversity Medical Center Göttingen, Göttingen, Germany.
Michael GhadimiUniversity Medical Center Göttingen, Göttingen, Germany.
Ralf-Dieter HofheinzUniversity Hospital Mannheim, Mannheim, Germany.
Claus RödelUniversity of Frankfurt, Frankfurt, Germany.
German Rectal Cancer Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTotal neoadjuvant therapy is a new paradigm for rectal cancer treatment. Optimal scheduling of preoperative chemoradiotherapy (CRT) and chemotherapy remains to be established. PATIENTS AND

methodsWe conducted a multicenter, randomized, phase II trial using a pick-the-winner design on the basis of the hypothesis of an increased pathologic complete response (pCR) of 25% after total neoadjuvant therapy compared with standard 15% after preoperative CRT. Patients with stage II or III rectal cancer were assigned to group A for induction chemotherapy using three cycles of fluorouracil, leucovorin, and oxaliplatin before fluorouracil/oxaliplatin CRT (50.4 Gy) or to group B for consolidation chemotherapy after CRT. Secondary end points included toxicity, compliance, and surgical morbidity.

resultsOf the 311 patients enrolled, 306 patients were evaluable (156 in group A and 150 in group B). CRT-related grade 3 or 4 toxicity was lower (37%

conclusionUp-front CRT followed by chemotherapy resulted in better compliance with CRT but worse compliance with chemotherapy compared with group A. Long-term follow-up will assess whether improved pCR in group B translates to better oncologic outcome.

Indexed as

Chemoradiotherapy, AdjuvantConsolidation ChemotherapyInduction ChemotherapyNeoadjuvant TherapyRadiation DosageAdenocarcinomaAgedAntineoplastic Combined Chemotherapy ProtocolsDrug Administration ScheduleFemaleGermanyHumansMaleMiddle AgedNeoplasm StagingRectal Neoplasms

Identifiers

PMID31150315

What OpenQuestion holds

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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.