Evidence map›Paper›PMID 33805731›Full record

ArticleCancers2021

Neoadjuvant Chemoradiation Combined with Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer.

Oliver J Ott, Cihan Gani, Lars H Lindner, Manfred Schmidt, Ulf Lamprecht, Sultan Abdel-Rahman, Axel Hinke, Thomas Weissmann, Arndt Hartmann, Rolf D Issels and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Cancers, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01716949 (Multi-institutional Phase I/II Study), 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
–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.

NCT01716949 phase1 / phase2unknown statusnot on this map

Multi-institutional Phase I/II Study: Neoadjuvant Chemoradiation With 5-FU (or Capecitabine) and Oxaliplatin Combined With Deep Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer

TypeinterventionalSponsorUniversity of Erlangen-Nürnberg Medical SchoolRan2012 to 2023Enrolled59ConditionsRectal CancerArmsRadiotherapy, Hyperthermia, 5-Fluorouracil, Capecitabine, Oxaliplatin
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Reirradiation - still navigating uncharted waters?Clinical and translational radiation oncology · 2024
    Review
  4. Review
  5. Review
  6. Application of nano-radiosensitizers in combination cancer therapy.Bioengineering & translational medicine · 2023
    Review
  7. A patterns of care analysis of hyperthermia in combination with radio(chemo)therapy or chemotherapy in European clinical centers.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
    Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. [Should neoadjuvant chemoradiation be combined with regional hyperthermia for rectal cancer?]Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2021
    Article
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

14 authors.

Oliver J OttDepartment of Radiation Oncology, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.ORCID 0000-0001-5806-6158
Cihan GaniDepartment of Radiation Oncology, Universitätsklinikum Tübingen, 72076 Tübingen, Germany.ORCID 0000-0003-0242-9428
Lars H LindnerDepartment of Medicine III, University Hospital, LMU Munich, 81377 Munich, Germany.ORCID 0000-0003-3708-8264
Manfred SchmidtDepartment of Radiation Oncology, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.
Ulf LamprechtDepartment of Radiation Oncology, Universitätsklinikum Tübingen, 72076 Tübingen, Germany.
Sultan Abdel-RahmanDepartment of Medicine III, University Hospital, LMU Munich, 81377 Munich, Germany.
Axel HinkeCancer Clinical Research Consulting (CCRC), 40595 Düsseldorf, Germany.
Thomas WeissmannDepartment of Radiation Oncology, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.
Arndt HartmannInstitute of Pathology, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.
Rolf D IsselsDepartment of Medicine III, University Hospital, LMU Munich, 81377 Munich, Germany.ORCID 0000-0002-3494-6561
Daniel ZipsDepartment of Radiation Oncology, Universitätsklinikum Tübingen, 72076 Tübingen, Germany.
Claus BelkaDepartment of Radiation Oncology, University Hospital, LMU Munich, 80377 Munich, Germany.
Robert GrützmannDepartment of Surgery, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.
Rainer FietkauDepartment of Radiation Oncology, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo prospectively analyze feasibility and pathological complete response (pCR) rates of neoadjuvant chemoradiotherapy combined with regional hyperthermia (RHT) in patients with locally advanced (LARC) or recurrent (LRRC) rectal cancer.

methodsbetween 2012 and 2018, 111 patients with UICC stage IIB-IV or any locally recurrent rectal cancer were included (HyRec-Trial, ClinicalTrials.gov Identifier: NCT01716949). Patients received radiotherapy with concurrent 5-Fluororuracil (5-FU)/Capecitabine and Oxaliplatin, and RHT. Stage 1 feasibility analysis evaluated dose-limiting toxicities (DLT) after 19 patients, stage 2 after 59 evaluable patients. Analysis of the pCR rate was based on histopathological reports.

resultsthe feasibility rates for stages 1 and 2 were 90% (17/19) and 73% (43/59), respectively. In the intention-to-treat population the pCR rate was 19% (20/105; 90% confidence interval (CI) 13.0-26.5). In the per-protocol-analysis, complete tumor regression was seen in 28% (18/64) and 38% (3/8) of the patients with LARC and LRRC, respectively. Complete resection rates (R0) among patients with LARC and LRRC who received surgery were 99% (78/84) and 67% (8/12).

conclusionsthe intensified neoadjuvant and multimodality treatment schedule was feasible and led to comparable early toxicity rates as described by other trials that used the similar chemoradiation protocol. The presented treatment regimen resulted in a very high pCR rate and appears as a promising option for patients with LRRC.

Indexed as

complete remission rateconcurrent chemoradiationlocally advanced rectal cancerlocally recurrent rectal cancerregional hyperthermiatumor regression grading

Identifiers

PMID33805731
PMCPMC8001688

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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.