Evidence map›Paper›PMID 25002723›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Postoperative chemoradiotherapy and cetuximab for high-risk squamous cell carcinoma of the head and neck: Radiation Therapy Oncology Group RTOG-0234.

Paul M Harari, Jonathan Harris, Merrill S Kies, Jeffrey N Myers, Richard C Jordan, Maura L Gillison, Robert L Foote, Mitchell Machtay, Marvin Rotman, Deepak Khuntia and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00084318 (A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck), which is not on this map. Cited by 84 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 6 pooled it
21.9field-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.

NCT00084318 phase2completednot on this map

A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck

TypeinterventionalSponsorRadiation Therapy Oncology GroupRan2004 to 2016Enrolled238ConditionsHead and Neck CancerArmscetuximab, cisplatin, docetaxel, radiation therapy
3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 6 syntheses or guidelines pooled it, 217 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Systemic therapy in the curative treatment of head and neck squamous cell cancer: a systematic review.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2017
    Pooled it
  7. Postoperative Radiotherapy ± Cetuximab for Intermediate-Risk Head and Neck Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. p16 protein expression and human papillomavirus status as prognostic biomarkers of nonoropharyngeal head and neck squamous cell carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014
    Trial
  17. Article
  18. Pretreatment Chromosomal Instability Correlates With Radiation Sensitivity in Squamous Cell Cancers.International journal of radiation oncology, biology, physics · 2026
    Article
  19. Review
  20. Article

24 more citing papers are in PubMed but not listed here.

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

13 authors at 7 institutions in 3 countries.

Paul M HarariPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO. harari@humonc.wisc.edu.
Jonathan HarrisPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Merrill S KiesPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Jeffrey N MyersPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Richard C JordanPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Maura L GillisonPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Robert L FootePaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Mitchell MachtayPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Marvin RotmanPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Deepak KhuntiaPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
William StraubePaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Qiang ZhangPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Kian AngPaul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.
Eli Lilly (Singapore) · SGBristol-Myers Squibb (Germany) · DEVarian Medical Systems (Germany) · DEState University of New York · USThe University of Texas MD Anderson Cancer Center · USUW Health University Hospital · USVarian Medical Systems (United States) · 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
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
National Clinical Trials Network Research at the University of WisconsinU10CA180799 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI ANDERSON, BETHANY M, KUSHNER, DAVID M · 2014 to 2018
$2.8M
NCI NIH HHS P30 CA016672NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA180799NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA21661NCI NIH HHS U10 CA37422NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeTo report results of a randomized phase II trial (Radiation Therapy Oncology Group RTOG-0234) examining concurrent chemoradiotherapy and cetuximab in the postoperative treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) with high-risk pathologic features. PATIENTS AND

methodsEligibility required pathologic stage III to IV SCCHN with gross total resection showing positive margins and/or extracapsular nodal extension and/or two or more nodal metastases. Patients were randomly assigned to 60 Gy radiation with cetuximab once per week plus either cisplatin 30 mg/m(2) or docetaxel 15 mg/m(2) once per week.

resultsBetween April 2004 and December 2006, 238 patients were enrolled. With a median follow-up of 4.4 years, 2-year overall survival (OS) was 69% for the cisplatin arm and 79% for the docetaxel arm; 2-year disease-free survival (DFS) was 57% and 66%, respectively. Patients with p16-positive oropharynx tumors showed markedly improved survival outcome relative to patients with p16-negative oropharynx tumors. Grade 3 to 4 myelosuppression was observed in 28% of patients in the cisplatin arm and 14% in the docetaxel arm; mucositis was observed in 56% and 54%, respectively. DFS in this study was compared with that in the chemoradiotherapy arm of the RTOG-9501 trial (Phase III Intergroup Trial of Surgery Followed by Radiotherapy Versus Radiochemotherapy for Resectable High Risk Squamous Cell Carcinoma of the Head and Neck), which had a hazard ratio of 0.76 for the cisplatin arm versus control (P = .05) and 0.69 for the docetaxel arm versus control (P = .01), reflecting absolute improvement in 2-year DFS of 2.5% and 11.1%, respectively.

conclusionThe delivery of postoperative chemoradiotherapy and cetuximab to patients with SCCHN is feasible and tolerated with predictable toxicity. The docetaxel regimen shows favorable outcome with improved DFS and OS relative to historical controls and has commenced formal testing in a phase II/III trial.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabChemoradiotherapy, AdjuvantCisplatinDisease-Free SurvivalDocetaxelFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedCetuximabCisplatinDocetaxelTaxoids

Identifiers

PMID25002723
PMCPMC4121506
OpenAlexW2159631730

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.