Evidence map›Paper›PMID 32679405›Full record

Trial reportOral oncology2020

A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.

Robert L Ferris, Yael Flamand, F Christopher Holsinger, Gregory S Weinstein, Harry Quon, Ranee Mehra, Joaquin J Garcia, Michael L Hinni, Neil D Gross, Erich M Sturgis and 23 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Oral oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
5.4field-weighted citation impact, top 2% 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.

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

23 citing papers in PubMed, 43 citations in OpenAlex.

  1. Analysis and objective assessment of transoral robotic surgery.International journal of computer assisted radiology and surgery · 2026
    Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. External Carotid Artery Ligation Versus Selective Artery Ligation in Transoral Surgery for Oropharyngeal Cancer.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2025
    Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. [De-escalation of adjuvant radiotherapy after transoral surgery of HPV-associated oropharyngeal cancer: results of the E3311 trial].Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2022
    Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Standardization for oncologic head and neck surgery.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2021
    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

33 authors at 20 institutions in 1 country.

Robert L FerrisUPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.
Yael FlamandDana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.
F Christopher HolsingerStanford University, Palo Alto, CA, United States.
Gregory S WeinsteinUniversity of Pennsylvania, Philadelphia, PA, United States.
Harry QuonJohns Hopkins University, Baltimore, MD, United States.
Ranee MehraUniversity of Maryland, Baltimore, MD, United States.
Joaquin J GarciaMayo Clinic, Rochester, MN, United States.
Michael L HinniMayo Clinic in Arizona, Phoenix, AZ, United States.
Neil D GrossThe University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.
Erich M SturgisThe University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.
Umamaheswar DuvvuriUPMC Hillman Cancer Center, Pittsburgh, PA, United States.
Eduardo MéndezUniversity of Washington, Seattle, WA, United States.
John A RidgeFox Chase Cancer Center, Philadelphia, PA, United States.
J Scott MagnusonFlorida Hospital Orlando, Celebration, FL, United States.
Kerry A HigginsECOG-ACRIN Cancer Research Group, Boston, MA, United States.
Mihir R PatelWinship Cancer Institute at Emory University, Atlanta, GA, United States.
Russel B SmithUniversity of Nebraska, Omaha, NE, United States.
Daniel W KaraklaSentara Norfolk General Hospital, Norfolk, VA, United States.
Michael E KupfermanThe University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.
James P MaloneUPMC Pinnacle Cancer Center, Harrisburg, PA, United States.
Benjamin L JudsonYale School of Medicine and Yale Cancer Center, New Haven, CT, United States.
Jeremy RichmonMassachusetts Eye and Ear, Harvard University, Boston, MA, United States.
Jay O BoyleMemorial Sloan Kettering Cancer Center, New York, NY, United States.
Rodrigo BayonUniversity of Iowa, Iowa City, IA, United States.
Bert W O'MalleyUniversity of Pennsylvania, Philadelphia, PA, United States.
Enver OzerThe Ohio State University, Columbus, OH, United States.
Giovana R ThomasUniversity of Miami Leonard Miller School of Medicine, Miami, FL, United States.
Wayne M KochJohns Hopkins University, Baltimore, MD, United States.
R Bryan BellProvidence Cancer Institute, Portland, OR, United States.
Nabil F SabaWinship Cancer Institute at Emory University, Atlanta, GA, United States.
Shuli LiDana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.
Elin R SigurdsonFox Chase Cancer Center, Philadelphia, PA, United States.
Barbara BurtnessYale School of Medicine and Yale Cancer Center, New Haven, CT, United States.
The University of Texas MD Anderson Cancer Center · USDana-Farber Cancer Institute · USEmory University · USFox Chase Cancer Center · USJohns Hopkins University · USUniversity of Pennsylvania · USYale Cancer Center · USAdventHealth Celebration · USECOG-ACRIN Cancer Research Group · USMassachusetts Eye and Ear Infirmary · USMayo Clinic Hospital · USMayo Clinic in Arizona · USMemorial Sloan Kettering Cancer Center · USPalo Alto University · USProvidence Portland Medical Center · USSentara Norfolk General Hospital · USThe Ohio State University · USUniversity of Iowa · USUniversity of Maryland, Baltimore · USUniversity of Miami · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer CenterUG1CA233184 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ADAM M BRUFSKY, John Munn Kirkwood · 2019 to 2026
$7.7M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS UG1 CA233184NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

purposeUnderstanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA. PATIENTS AND

methodsE3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.

results120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.

conclusionsWe provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.

Indexed as

AdultAgedFemaleHumansMiddle AgedOropharyngeal NeoplasmsProspective StudiesQuality Assurance, Health CareRobotic Surgical ProceduresSurgeonsHead and neck cancerHPVQuality assuranceTransoral surgery

Identifiers

PMID32679405
PMCPMC7771718
OpenAlexW3043334092

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Registered trials

None linked

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.