Evidence map›Paper›PMID 34699271›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Phase II Randomized Trial of Transoral Surgery and Low-Dose Intensity Modulated Radiation Therapy in Resectable p16+ Locally Advanced Oropharynx Cancer: An ECOG-ACRIN Cancer Research Group Trial (E3311).

Robert L Ferris, Yael Flamand, Gregory S Weinstein, Shuli Li, Harry Quon, Ranee Mehra, Joaquin J Garcia, Christine H Chung, Maura L Gillison, Umamaheswar Duvvuri and 10 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 229 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
229citing papers in PubMed, 13 pooled it
49.6field-weighted citation impact, top 1% 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.

NCT01898494 phase2active not recruitingnot on this map

Phase II Randomized Trial of Transoral Surgical Resection Followed by Low-Dose or Standard-Dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

TypeinterventionalSponsorECOG-ACRIN Cancer Research GroupRan2014 to 2026Enrolled519ConditionsHuman Papilloma Virus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the OropharynxArmsTransoral surgery, intensity-modulated radiation therapy, cisplatin, carboplatin
NCT06578871 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Surgery for the Unknown Primary in the Era of p16-positive Oropharyngeal Squamous Cell Carcinoma: Reducing Ionizing Radiation (SUPERIOR): A Randomized Trial

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2025 to 2027Enrolled90ConditionsHead and Neck Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell CarcinomaArmsIntensity Modulated Radiotherapy (IMRT) to Mucosa at Risk, Surgical Intervention, Intensity Modulated Radiotherapy (IMRT) to Ipsilateral Neck
3 · Its place in the literature

Who cites it

229 citing papers in PubMed, 13 syntheses or guidelines pooled it, 405 citations in OpenAlex.

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  6. Oncologic Outcomes of Transoral Robotic Surgery in HPV-Associated OPSCC: A Systematic Review and Meta-Analysis.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026
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  9. Surgical margins after open versus transoral surgery for oropharyngeal cancer and their impact on the need for multimodal treatments.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2025
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  20. Postoperative Radiotherapy ± Cetuximab for Intermediate-Risk Head and Neck Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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169 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 15 institutions in 1 country.

Robert L FerrisUPMC Hillman Cancer Center, Pittsburgh, PA.ORCID 0000-0001-6605-2071
Yael FlamandDana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.
Gregory S WeinsteinUniversity of Pennsylvania, Philadelphia, PA.
Shuli LiDana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.
Harry QuonJohns Hopkins University, Baltimore, MD.ORCID 0000-0001-7605-4329
Ranee MehraUniversity of Maryland, Baltimore, MD.ORCID 0000-0003-2477-9584
Joaquin J GarciaMayo Clinic, Rochester, MN.
Christine H ChungMoffitt Cancer Center, Tampa FL.ORCID 0000-0001-5199-4306
Maura L GillisonThe University of Texas, MD Anderson Cancer Center, Houston, TX.
Umamaheswar DuvvuriUPMC Hillman Cancer Center, Pittsburgh, PA.
Bert W O'MalleyUniversity of Pennsylvania, Philadelphia, PA.
Enver OzerThe Ohio State University, Columbus, OH.
Giovana R ThomasUniversity of Miami, Miami, FL.
Wayne M KochJohns Hopkins University, Baltimore, MD.
Neil D GrossThe University of Texas, MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-9427-0743
R Bryan BellProvidence Cancer Institute, Portland, OR.ORCID 0000-0002-3775-109X
Nabil F SabaWinship Cancer Institute at Emory University, Atlanta, GA.ORCID 0000-0003-4972-1477
Miriam LangoFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0003-0736-7473
Eduardo MéndezUniversity of Washington, Seattle, WA.
Barbara BurtnessYale School of Medicine and Yale Cancer Center, New Haven, CT.ORCID 0000-0003-4660-1859
Dana-Farber Cancer Institute · USJohns Hopkins University · USThe University of Texas MD Anderson Cancer Center · USUniversity of Pennsylvania · USUPMC Hillman Cancer Center · USEmory University · USFox Chase Cancer Center · USMayo Clinic in Arizona · USMoffitt Cancer Center · USProvidence Portland Medical Center · USThe Ohio State University · USUniversity of Maryland, Baltimore · USUniversity of Miami · USUniversity of Washington · USYale Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
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
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
The Pacific Cancer Research Consortium (PCRC), an NCORP Community SiteUG1CA189953 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI Alison Katherine Conlin, Charles Drescher · 2014 to 2026
$27.4M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP) UG1UG1CA233329 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KELLY K HUNT, CHELSEA Camille PINNIX · 2019 to 2026
$11.1M
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, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
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
Winship National Clinical Trials Network Lead Academic Participating SiteUG1CA233247 · NCI · EMORY UNIVERSITY · PI Ashesh Jani, NABIL F SABA · 2019 to 2026
$6.0M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA016672NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189953NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233184NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233247NCI NIH HHS UG1 CA233328NCI NIH HHS UG1 CA233329NCI NIH HHS UG1 CA233331NCI NIH HHS UG1 CA233337
6 · The paper itself

Abstract

purposeDefinitive or postoperative chemoradiation (CRT) is curative for human papillomavirus-associated (HPV+) oropharynx cancer (OPC) but induces significant toxicity. As a deintensification strategy, we studied primary transoral surgery (TOS) and reduced postoperative radiation therapy (RT) in intermediate-risk HPV+ OPC.

methodsE3311 is a phase II randomized trial of reduced- or standard-dose postoperative RT for resected stage III-IVa (American Joint Committee on Cancer-seventh edition) HPV+ OPC, determined by pathologic parameters. Primary goals were feasibility of prospective multi-institutional study of TOS for HPV+ OPC, and oncologic efficacy (2-year progression-free survival) of TOS and adjuvant therapy in intermediate-risk patients after resection. TOS plus 50 Gy was considered promising if the lower limit of the exact 90% binomial confidence intervals exceeded 85%. Quality of life and swallowing were measured by functional assessment of cancer therapy-head and neck and MD Anderson Dysphagia Index.

resultsCredentialed surgeons performed TOS for 495 patients. Eligible and treated patients were assigned as follows: arm A (low risk, n = 38) enrolled 11%, intermediate risk arms B (50 Gy, n = 100) or C (60 Gy, n = 108) randomly allocated 58%, and arm D (high risk, n = 113) enrolled 31%. With a median 35.2-month follow-up for 359 evaluable (eligible and treated) patients, 2-year progression-free survival Kaplan-Meier estimate is 96.9% (90% CI, 91.9 to 100) for arm A (observation), 94.9% (90% CI, 91.3 to 98.6]) for arm B (50 Gy), 96.0% (90% CI, 92.8 to 99.3) for arm C (60 Gy), and 90.7% (90% CI, 86.2 to 95.4) for arm D (66 Gy plus weekly cisplatin). Treatment arm distribution and oncologic outcome for ineligible or step 2 untreated patients (n = 136) mirrored the 359 evaluable patients. Exploratory comparison of functional assessment of cancer therapy-head and neck total scores between arms B and C is presented.

conclusionPrimary TOS and reduced postoperative RT result in outstanding oncologic outcome and favorable functional outcomes in intermediate-risk HPV+ OPC.

Indexed as

PharyngectomyRadiotherapy, Intensity-ModulatedAdultAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorChemoradiotherapy, AdjuvantCisplatinCyclin-Dependent Kinase Inhibitor p16Feasibility StudiesFemaleHumansMaleMiddle AgedOropharyngeal NeoplasmsAntineoplastic AgentsBiomarkers, TumorCDKN2A protein, humanCisplatinCyclin-Dependent Kinase Inhibitor p16

Identifiers

PMID34699271
PMCPMC8718241
OpenAlexW3210105851

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.