Evidence map›Paper›PMID 32727416›Full record

ArticleBMC cancer2020

Comparative effectiveness trial of transoral head and neck surgery followed by adjuvant radio(chemo)therapy versus primary radiochemotherapy for oropharyngeal cancer (TopROC).

Lara Bußmann, Simon Laban, Claus Wittekindt, Carmen Stromberger, Silke Tribius, Nikolaus Möckelmann, Arne Böttcher, Christian Stephan Betz, Jens Peter Klussmann, Volker Budach and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03691441 (Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% 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.

NCT03691441 phase4unknown statusnot on this map

Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer

TypeinterventionalSponsorUniversitätsklinikum Hamburg-EppendorfRan2018 to 2024Enrolled280ConditionsOropharyngeal CancerArmsResection, Radiotherapy, Chemotherapy, Salvage neck dissection
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
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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

12 authors at 5 institutions in 1 country.

Lara BußmannDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Hamburg Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Simon LabanDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Ulm, Ulm, Germany.
Claus WittekindtDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Gießen, Gießen, Germany.
Carmen StrombergerDepartment of Radiation Oncology, Charité University Medicine Berlin, Berlin, Germany.
Silke TribiusHermann-Holthusen-Institut for Radiation Oncology, Asklepios Klinik St. Georg, Hamburg, Germany.
Nikolaus MöckelmannDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Hamburg Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Arne BöttcherDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Hamburg Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Christian Stephan BetzDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Hamburg Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Jens Peter KlussmannDepartment of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
Volker BudachDepartment of Radiation Oncology, Charité University Medicine Berlin, Berlin, Germany.
Adrian MuenscherDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Hamburg Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Chia-Jung BuschDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Hamburg Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany. cjbusch@uke.de.ORCID http://orcid.org/0000-0001-8254-8237
Universität Hamburg · DECharité - Universitätsmedizin Berlin · DEAsklepios Klinik St. Georg · DEUniversity Hospital Ulm · DEUniversity of Cologne · DE

Funding

Deutsche Krebshilfe 1120027
6 · The paper itself

Abstract

backgroundFor loco-regionally advanced, but transorally resectable oropharyngeal cancer (OPSCC), the current standard of care includes surgical resection and risk-adapted adjuvant (chemo) radiotherapy, or definite chemoradiation with or without salvage surgery. While transoral surgery for OPSCC has increased over the last decade for example in the United States due to transoral robotic surgery, this treatment approach has a long history in Germany. In contrast to Anglo-Saxon countries, transoral surgical approaches have been used frequently in Germany to treat patients with oro-, hypopharyngeal and laryngeal cancer. Transoral laser microsurgery (TLM) has had a long tradition since its introduction in the early 70s. To date, the different therapeutic approaches to transorally resectable OPSCC have not been directly compared to each other in a randomized trial concerning disease control and survival. The goal of this study is to compare initial transoral surgery to definitive chemoradiation for resectable OPSCC, especially with regards to local and regional control.

methodsTopROC is a prospective, two-arm, open label, multicenter, randomized, and controlled comparative effectiveness study. Eligible patients are ≥18 years old with treatment-naïve, histologically proven OPSCC (T1, N2a-c, M0; T2, N1-2c, M0; T3, N0-2c, M0 UICC vers. 7) which are amenable to transoral resection. Two hundred eighty patients will be randomly assigned (1:1) to surgical treatment (arm A) or chemoradiation (arm B). Standard of care treatment will be performed according to daily routine practice. Arm A consists of transoral surgical resection with neck dissection followed by risk-adapted adjuvant therapy. Patients treated in arm B receive standard chemoradiation, residual tumor may be subject to salvage surgery. Follow-up visits for 3 years are planned. Primary endpoint is time to local or locoregional failure (LRF). Secondary endpoints include overall and disease free survival, toxicity, and patient reported outcomes. Approximately 20 centers will be involved in Germany. This trial is supported by the German Cancer Aid and accompanied by a scientific support program. DISCUSSION: This study will shed light on an urgently-needed randomized comparison of the strategy of primary chemoradiation vs. primary surgical approach. As a comparative effectiveness trial, it is designed to provide data based on two established regimens in daily clinical routine.

trial registrationNCT03691441 Registered 1 October 2018 - Retrospectively registered.

Indexed as

Carcinoma, Squamous CellChemoradiotherapy, AdjuvantOral Surgical ProceduresOropharyngeal NeoplasmsAdultAntineoplastic AgentsCause of DeathCisplatinFluorouracilGermanyHumansMargins of ExcisionMitomycinMulticenter Studies as TopicNeck DissectionProspective StudiesAntineoplastic AgentsCisplatinFluorouracilMitomycinComparative effectiveness trialHead and neck cancerOropharynxQuality of lifeRadiotherapyRandomized controlled trialSurvivalTransoral surgery

Identifiers

PMID32727416
PMCPMC7389683
OpenAlexW3045561781

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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.