Evidence map›Paper›PMID 31192355›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2019

Long-course preoperative chemoradiation versus 5 × 5 Gy and consolidation chemotherapy for clinical T4 and fixed clinical T3 rectal cancer: long-term results of the randomized Polish II study.

B Ciseł, L Pietrzak, W Michalski, L Wyrwicz, A Rutkowski, E Kosakowska, A Cencelewicz, M Spałek, W Polkowski, M Jankiewicz and 21 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIComparative StudyEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 150 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
150citing papers in PubMed, 12 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.

NCT00833131 phase3unknown statusnot on this map

Short-course Preoperative Radiotherapy With Consolidating Chemotherapy vs. Preoperative Chemoradiation in Patients With Unresectable Rectal Cancer: Phase III Study

TypeinterventionalSponsorPolish Colorectal Cancer Study GroupRan2008 to 2015Enrolled540ConditionsRectal CancerArmsShort course of radiotherapy, Radiochemotherapy
NCT04231552 phase1 / phase2unknown statusnot on this map

Preoperative Short Course Radiotherapy With Consolidation Chemotherapies and Camrelizumab Followed by Delayed Surgery in Locally Advanced Rectal Cancer

TypeinterventionalSponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRan2019 to 2023Enrolled30ConditionsRectal Cancer, Radiotherapy, ImmunotherapyArmsCamrelizumab
NCT07651007 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase II Clinical Study of Short-course Radiotherapy Followed by NALIRIFOX Plus Pemolivimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS/pMMR

TypeinterventionalSponsorWang XinRan2026 to 2029Enrolled29ConditionsAdvanced Rectal CancerArmsiTNT-HX02
3 · Its place in the literature

Who cites it

150 citing papers in PubMed, 12 syntheses or guidelines pooled it.

  1. Pooled it
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  3. SEOM-GEMCAD-TTD clinical guidelines for localized rectal cancer (2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Guideline
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  5. Pooled it
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  13. Trial
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  17. SABR for High-Risk Prostate Cancer: A Prospective Multilevel MRI-Based Dose Escalation Trial.International journal of radiation oncology, biology, physics · 2022
    Trial
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  19. Total neoadjuvant therapy for rectal cancer: where are we now, where do we go?Clinical and translational radiation oncology · 2026
    Review
  20. Article

90 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors.

B CisełDepartment of Surgical Oncology, Medical University of Lublin, Lublin.
L PietrzakII Department of Radiotherapy.
W MichalskiBioinformatics and Biostatistics Unit.
L WyrwiczDepartments of Clinical Oncology.
A RutkowskiGastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw.
E KosakowskaGastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw.
A CencelewiczGastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw.
M SpałekII Department of Radiotherapy.
W PolkowskiDepartment of Surgical Oncology, Medical University of Lublin, Lublin.
M JankiewiczDepartment of Surgical Oncology, Medical University of Lublin, Lublin; Department of Radiotherapy, St. John's Cancer Center, Lublin.
R Styliński1st Department of General Surgery, Transplantology and Nutritional Therapy Medical University of Lublin.
M BębenekDepartments of Surgery.
B KapturkiewiczDepartments of Surgery.
A MaciejczykRadiotherapy, Silesian Oncological Centre, Wrocław.
J SadowskiDepartment of Radiotherapy, Regional Oncological Centre, Kielce.
J ZygulskaDepartment of Radiotherapy, Beskid Centre of Oncology, Bielsko-Biala.
W ZegarskiDepartments of Oncological Surgery.
M JankowskiDepartments of Oncological Surgery.
M Las-JankowskaClinical Oncology, Collegium Medicum Nicolaus Copernicus University and Oncology Centre, Bydgoszcz.
Z ToczkoDepartment of Surgery, Regional Hospital, Elblag.
U Żelazowska-OmiotekDepartment of Radiotherapy, Regional Cancer Centre, Tarnów.
L KępkaDepartment of Radiotherapy, Military Institute of Medicine, Warsaw.
J SochaDepartment of Radiotherapy, Military Institute of Medicine, Warsaw; Department of Radiotherapy, Regional Oncology Center, Czestochowa.
E Wasilewska-TeslukRadiotherapy Department, Public Health Care Facility of the Ministry of the Interior and Warmian-Masurian Oncology Centre, Olsztyn; Department of Oncology, University of Warmia and Mazury, Olsztyn.
W MarkiewiczDepartment of Surgery, Regional Cancer Centre, Białystok.
J KładnyDepartment of General Surgery and Surgical Oncology First Clinical Hospital of Pomeranian Medical University, Szczecin.
A MajewskiDepartment of Surgery, Regional Hospital, Wałbrzych.
W KapuścińskiDepartment of Radiotherapy, Regional Cancer Centre, Copernicus Memorial Hospital of Łódź, Łódź.
R SuwińskiDepartment of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Gliwice, Poland.
K BujkoII Department of Radiotherapy. Electronic address: krzysztof.bujko@coi.pl.
Polish Colorectal Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis trial evaluated whether preoperative short-course radiotherapy and consolidation chemotherapy (CCT) were superior to chemoradiation in rectal cancers with clinical (c)T4 or fixed cT3. Previously, we reported early results showing no differences in the radical surgery rate (primary end point). In the short-course/CCT group, we observed lower acute toxicity of preoperative treatment and better overall survival (OS). We updated results to determine whether the benefit in OS was sustained and to evaluate late complications. PATIENTS AND

methodsPatients with cT4 or fixed cT3 rectal cancer were randomized either to preoperative 5 × 5 Gy and three cycles of FOLFOX4 or to chemoradiation (50.4 Gy with bolus 5-Fu, leucovorin and oxaliplatin).

resultsPatients (N = 515) were eligible for analysis, 261 in the short-course/CCT group and 254 in the chemoradiation group. The median follow-up was 7.0 years. The difference in OS was insignificant [hazard ratio (HR) 0.90; 95% confidence interval (CI) 0.70-1.15; P = 0.38). However, the difference in early OS favouring short-course/CCT previously reported was observed again, being 9% at 3 years (95% CI 0.5% to 17%). This difference disappeared later; at 8 years OS was 49% in both groups. There was no difference in disease-free survival (HR 0.95; 95% CI 0.75-1.19; P = 0.65) at 8 years 43% versus 41% in the short-course/CCT group versus the chemoradiation group, respectively. The corresponding values for cumulative incidences of local failure and distant metastases did not differ and were HR = 1.08, 95% CI 0.70-1.23, P = 0.60, 35% versus 32% and HR = 1.10, 95% CI 0.68-1.23, P = 0.54, 36% versus 34%, respectively. The rate of late complications was similar (P = 0.66), grade 3+ being 11% versus 9% in the short-course/CCT group versus the chemoradiation group, respectively.

conclusionThe superiority of preoperative short-course/CCT over chemoradiation was not demonstrated. CLINICAL TRIAL NUMBER: The trial is registered as ClinicalTrials.gov number NCT00833131.

Indexed as

Dose Fractionation, RadiationAdolescentAdultAgedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyConsolidation ChemotherapyDisease-Free SurvivalFemaleFluorouracilFollow-Up StudiesHumansIncidenceLeucovorinMaleMiddle AgedFluorouracilLeucovorinOrganoplatinum Compoundspreoperative chemoradiationrectal cancer

Identifiers

PMID31192355

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.