Evidence map›Paper›PMID 40056849›Full record

Trial reportESMO open2025

Chemotherapy before or after preoperative chemoradiotherapy and surgery for locally advanced rectal cancer: 5-year results of the CAO/ARO/AIO-12 trial - a general pairwise comparison.

M Diefenhardt, R Kosmala, M Fleischmann, D Martin, R-D Hofheinz, M Ghadimi, C Rödel, B Polat, E Fokas

Abstract readRandomized Controlled TrialClinical Trial, Phase IIComparative Study
In one paragraph

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
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.

M DiefenhardtGoethe-University Frankfurt, University Hospital, Department of Radiotherapy, Frankfurt, Germany; Frankfurt Cancer Institute, Frankfurt, Germany. Electronic address: Diefenhardt@med.uni-frankfurt.de.
R KosmalaUniversity Würzburg, University Hospital, Department of Radiation Oncology, Würzburg, Germany.
M FleischmannGoethe-University Frankfurt, University Hospital, Department of Radiotherapy, Frankfurt, Germany.
D MartinGoethe-University Frankfurt, University Hospital, Department of Radiotherapy, Frankfurt, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany; German Cancer Consortium (DKTK), Partner Site Frankfurt am Main, Frankfurt, Germany.
R-D HofheinzDepartment of Hematology and Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
M GhadimiUniversity Göttingen, University Hospital, Department of General, Visceral and Pediatric Surgery, Göttingen, Germany.
C RödelGoethe-University Frankfurt, University Hospital, Department of Radiotherapy, Frankfurt, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany; German Cancer Consortium (DKTK), Partner Site Frankfurt am Main, Frankfurt, Germany.
B PolatUniversity Würzburg, University Hospital, Department of Radiation Oncology, Würzburg, Germany.
E FokasGoethe-University Frankfurt, University Hospital, Department of Radiotherapy, Frankfurt, Germany; Frankfurt Cancer Institute, Frankfurt, Germany; University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Radiation Oncology, Cyberknife and Radiation Therapy, Cologne, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTotal neoadjuvant treatment (TNT) has been increasingly adopted for multimodal rectal cancer treatment. Here, we present the 5-year results of our CAO/ARO/AIO-12 randomized phase II trial that compared two TNT sequences. PATIENTS AND

methodsPatients were initially randomized 1 : 1 to arm A (induction chemotherapy followed by chemoradiotherapy) or arm B (chemoradiotherapy followed by consolidation chemotherapy) followed by total mesorectal excision surgery. This report on the 5-year results involved a general pairwise comparison (GPC) of the following parameters, ranked as indicated: overall survival, incidence of locoregional recurrence, incidence of distant metastasis, rate of pathological/clinical complete remission, long-term quality of life (at least 24 months after randomization) based on global health assessed by the European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire Core 30 questionnaire, and incidence of toxicity, ranked by grade, during follow-up.

resultsA total of 306 patients were eligible for this analysis. After a median follow-up of 60 months (interquartile range 58-62 months), we found that long-term oncological outcome was comparable in both arms [e.g. 5-year overall survival 85.8% (95% confidence interval 80.2% to 91.8%) in arm A and 84.2% (95% confidence interval 78.2% to 90.5%) in arm B], regardless of whether patients received induction chemotherapy and chemoradiotherapy or chemoradiotherapy and consolidation chemotherapy. The GPC showed no clinically meaningful overall treatment benefit (-1.38%) or win ratio difference (0.97) between the two treatment sequences. The incidence of pathological or sustained clinical complete remission remained higher in patients treated with consolidation chemotherapy after adjusting for long-term outcome between both arms (11% versus 6.5%).

conclusionsOur 5-year GPC confirmed the 3-year findings that chemoradiotherapy followed by consolidation chemotherapy resulted in higher rates of pathological complete remission without compromising oncological outcome, toxicity, or quality of life. The TNT sequence chemoradiotherapy/chemotherapy may be preferred for organ preservation strategies.

Indexed as

ChemoradiotherapyNeoadjuvant TherapyRectal NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedQuality of LifeTreatment Outcomeclinical trialgeneral pairwise comparisonradiotherapyrectal cancertotal neoadjuvant treatment

Identifiers

PMID40056849
PMCPMC11930669

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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.