Evidence map›Paper›PMID 33741467›Full record

Trial reportRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology2021

Deep regional hyperthermia with preoperative radiochemotherapy in locally advanced rectal cancer, a prospective phase II trial.

Cihan Gani, Ulf Lamprecht, Alexander Ziegler, Matthias Moll, Johanna Gellermann, Vanessa Heinrich, Svetlana Wenz, Falko Fend, Alfred Königsrainer, Michael Bitzer and 1 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02353858 (Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 11% 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.

NCT02353858 phase2completednot on this map

Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial

TypeinterventionalSponsorUniversity Hospital TuebingenRan2012 to 2017Enrolled78ConditionsRectal Cancer, Locally Advanced Rectal Cancer, Hyperthermia, Hyperthermic RadiochemotherapyArmsDeep regional hyperthermia, Radiotherapy, Chemotherapy (5-Fluorouracil)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
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  15. [Should neoadjuvant chemoradiation be combined with regional hyperthermia for rectal cancer?]Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2021
    Article
  16. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 2 countries.

Cihan GaniUniversity Hospital Tübingen, Department of Radiation Oncology, Germany; German Cancer Research Center (DKFZ) Heidelberg and German Consortium for Translational Cancer Research (DKTK), Partner Site Tübingen, Germany. Electronic address: cihan.gani@med.uni-tuebingen.de.
Ulf LamprechtUniversity Hospital Tübingen, Department of Radiation Oncology, Germany.
Alexander ZieglerDepartment of Internal Medicine, Oncology/Hematology, Gastroenterology, Hospital Esslingen GmbH, Germany.
Matthias MollDepartment of Radiation Oncology, Medical University of Vienna, Wien, Austria.
Johanna GellermannPraxis/Zentrum für Strahlentherapie und Radioonkologie, Berlin, Germany.
Vanessa HeinrichUniversity Hospital Tübingen, Department of Radiation Oncology, Germany.
Svetlana WenzInstitute of Pathology and Neuropathology, Eberhard-Karls University, Tuebingen, Germany.
Falko FendGerman Cancer Research Center (DKFZ) Heidelberg and German Consortium for Translational Cancer Research (DKTK), Partner Site Tübingen, Germany; Institute of Pathology and Neuropathology, Eberhard-Karls University, Tuebingen, Germany.
Alfred KönigsrainerUniversity Hospital Tübingen, Department of General, Visceral and Transplant Surgery, Germany.
Michael BitzerUniversity Hospital Tübingen, Department of Internal Medicine I, Germany.
Daniel ZipsUniversity Hospital Tübingen, Department of Radiation Oncology, Germany; German Cancer Research Center (DKFZ) Heidelberg and German Consortium for Translational Cancer Research (DKTK), Partner Site Tübingen, Germany.
German Cancer Research Center · DEUniversity Children's Hospital Tübingen · DEUniversity of Tübingen · DEKlinikum Esslingen · DEKlinik und Poliklinik für Strahlentherapie und Radioonkologie · DEMedical University of Vienna · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe goal of the present study was to investigate the effect of deep regional hyperthermia on early and long-term oncological outcomes in the context of preoperative radiochemotherapy in rectal cancer.

methodsIn this prospective phase II trial, patients with locally advanced rectal cancer were treated with 5-fluorouracil based preoperative radiochemotherapy with 50.4 Gy in 28 fractions. Deep regional hyperthermia was scheduled twice weekly. Pathological tumor regression was scored according to the Dworak regression system. The primary endpoint was pathological complete response (pCR). Further endpoints were local control (LC), distant control (DC), disease-free survival (DFS) and overall survival (OS). Hyperthermia was defined as feasible if 70% of patients received at least eight treatments. Quality of life was assessed at follow-up by the EORTC-QLQ-C30 and QLQ-CR29 questionnaires. Time to event data was analyzed according to Kaplan-Meier based on first-events. The study was registered on clinicaltrials.gov (NCT02353858).

resultsFrom 2012 until 2017, 78 patients were recruited. Median follow-up was 54 months. Based on magnetic resonance imaging, the mesorectal fascia was involved or threatened in 60% of the patients. Compliance with radiotherapy was 99%, 91% received both cycles of chemotherapy and 77% had eight or more hyperthermia treatments. Median time from the end of radiotherapy to surgery was 6.7 weeks. A pathological complete response was reported in 14% of the patients, 50% had either Dworak 4 (complete regression) or Dworak 3 regression (scattered tumor cells only). Three year estimates for OS, DFS, LC and DC were 94%, 81%, 96% and 87%. Patients with higher hyperthermia related cumulative temperatures showed stronger tumor regression. Global health status based on EORTC-QLQ-C30 was comparable with data from the general population.

conclusionDeep regional hyperthermia was feasible, did not compromise standard treatments and resulted in promising long-term oncological outcomes and QoL.

Indexed as

AdenocarcinomaRectal NeoplasmsChemoradiotherapyFluorouracilHumansHyperthermiaNeoadjuvant TherapyNeoplasm StagingProspective StudiesQuality of LifeTreatment OutcomeFluorouracilHyperthermiaRadiochemotherapyRectal cancer

Identifiers

PMID33741467
OpenAlexW3137809671

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.