Evidence map›Paper›PMID 40829719›Full record

Trial reportInternational journal of radiation oncology, biology, physics2026

Self-Perceived Hearing Outcomes With Radiation and Cisplatin or Radiation and Cetuximab for Patients With Human Papilloma Virus (HPV)-Positive Oropharyngeal Cancer-Results From NRG Oncology RTOG 1016.

Christina L Runge, Jessica A Lyness, Maura L Gillison, David J Adelstein, Paul M Harari, Jolie Ringash, Jessica L Geiger, Greg A Krempl, Dukagjin M Blakaj, James Edward Bates and 11 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

21 authors.

Christina L RungeKeck School of Medicine, University of Southern California, Los Angeles, California. Electronic address: Christina.Runge@med.usc.edu.
Jessica A LynessNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Maura L GillisonMD Anderson Cancer Center, Houston, Texas.
David J AdelsteinCleveland Clinic Foundation, Cleveland, Ohio.
Paul M HarariUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin.
Jolie RingashUniversity Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada.
Jessica L GeigerCleveland Clinic Foundation, Cleveland, Ohio.
Greg A KremplUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.
Dukagjin M BlakajOhio State University Comprehensive Cancer Center, Columbus, Ohio.
James Edward BatesEmory University Hospital Midtown, Atlanta, Georgia.
Thomas J GallowayFox Chase Cancer Center, Philadelphia, Pennsylvania.
Christopher U JonesSutter Medical Center Sacramento, Roseville, California.
Michael F GensheimerStanford Cancer Institute Palo Alto, Stanford, California.
Neal E DunlapThe James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky.
Jack PhanMD Anderson Cancer Center, Houston, Texas.
Jimmy J CaudellMoffitt Cancer Center, Tampa, Florida.
J Daniel PenningtonSoutheast Clinical Oncology Research Consortium NCORP, Winston-Salem, North Carolina.
Pedro A Torres-SaavedraBiometric Research Program, National Cancer Institute, Bethesda, Maryland (This work was performed while employed by NRG Oncology, Philadelphia, Pennsylvania).
Sue S YomUCSF Medical Center-Mount Zion, San Francisco, California.
Quynh-Thu LeStanford Cancer Institute Palo Alto, Stanford, California.
Benjamin MovsasHenry Ford Cancer Institute, Detroit, Michigan.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
IROC: Enhancing local enrolling site radiological data capture capabilities for NCTN trialsU24CA180803 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI Thomas J. FitzGerald, MICHAEL V KNOPP · 2014 to 2026
$116.2M
NRG Oncology Biospecimen BankU24CA196067 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Tanner J. Freeman, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$42.6M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
National Clinical Trials Network Research at the University of WisconsinUG1CA233277 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Lisa M Barroilhet, Andrew M. Baschnagel · 2019 to 2026
$4.9M
NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA180803NCI NIH HHS U24 CA196067NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA233277
6 · The paper itself

Abstract

purposeRTOG 1016 was a noninferiority phase III trial comparing the efficacy of radiation with either cisplatin (RT + Cis) or cetuximab (RT + Cetux) for patients with Humman Papillomavirus (HPV)+ oropharyngeal cancer (OPC). Perceived hearing handicap was included as a patient-reported outcome (PRO) secondary endpoint. The primary hypothesis was that perceived hearing handicap would be greater for patients receiving RT + Cis compared with RT + Cetux. METHODS AND MATERIALS: Perceived hearing handicap was measured at baseline, end of treatment, and 3, 6, and 12 months posttreatment using the Hearing Handicap Inventory for Adults Screening Version (HHIA-S), a 10-item self-assessment questionnaire designed to measure patients' reactions to their hearing loss. Mixed ordinal logistic models were used to determine the treatment effect on HHIA-S scores and handicap categories (2-sided α = 0.05).

resultsThe PRO substudy included 375 eligible patients. No significant differences in patient/tumor characteristics were found between patients who participated in the HHIA-S study versus those excluded. For total HHIA-S scores and social and emotional subscales, RT + Cetux had significantly lower (ie, better) scores from end of treatment. Change score from baseline to end of treatment for RT + Cis (4.32; 95% confidence interval [CI], 2.57-6.07]) was greater than RT + Cetux (0.08; 95% CI, -1.15 to 1.31). For hearing handicap category, RT + Cis had a significantly higher percentage of mild/moderate and severe cases at the end of treatment (32%) compared with RT + Cetux (20%) (P < .0001). Adjusted conditional odds of higher self-perceived hearing handicap category for RT + Cis compared with RT + Cetux was 3.73 (95% CI, 2.10-6.62).

conclusionPatients have significantly worse self-perceived hearing handicap after receiving RT + Cis treatment than with RT + Cetux. This was consistent across time through 1 year posttreatment. These findings inform hearing-related outcomes for patients with HPV-associated OPC and indicate the need for ototoxicity monitoring with RT + Cis treatment.

Indexed as

CetuximabChemoradiotherapyCisplatinHearing LossOropharyngeal NeoplasmsPapillomavirus InfectionsAdultAgedAntineoplastic AgentsFemaleHuman Papillomavirus VirusesHumansMaleMiddle AgedPapillomaviridaePatient Reported Outcome MeasuresAntineoplastic AgentsCetuximabCisplatin

Identifiers

PMID40829719
PMCPMC12637033

What OpenQuestion holds

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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.