RTOG-0920 (NRG-RTOG 0920)

Rodrigo Arrangoiz MS, MD, FACS, FSSO
  • Who was studied?
    • Population: 
      • Completely resected, intermediate-risk HNSCC of:
        • Oral cavity, oropharynx, or larynx:
          • Hypopharynx excluded
      • Intermediate-risk factors included any of: 
        • Pernineural invasion (PNI)
        • Lymphovascular ivasion (LVI)
        • ≥ 2 lymph nodes (LNs) (all < 6 cm) or one LN > 3 cm (no extranodal extension (ENE))
        • Close margin(s) < 5 mm or focally positive then re-resected negative
        • pT3 to pT4a primary, or T2 oral cavity with DOI > 5 mm ozarkscancerresearch.org
      • Key baseline notes: 
        • Majority HPV-negative (~ 80%)
        • Oral cavity ~ 64%
        • EGFR high expression in ~ 85%(assayed for stratification, not a requirement) NRG Oncology+1
    • Study design and treatment:
      • Randomization (1:1): 
        • PORT alone vs PORT + cetuximab
      • PORT: 
      • Cetuximab regimen: 
        • 400 mg/m² loading, then 250 mg/m² weekly x 6 during RT + 4 weekly doses post-RT (total 11) ozarkscancerresearch.org
      • Primary endpoint: 
        • Overall survival (OS) in all randomized / eligible
          • Pre-specified plan to test in HPV-negative subgroup
      • Secondary endpoints: 
        • Disease-free survival (DFS), toxicity, others PubMed
    • Results (median follow-up ~ 7.2 years):
      • Primary endpoint (OS): Negative:
        • OS HR 0.81; one-sided p=0.075 (did not meet significance)
        • 5-yr OS: 
      • Secondary endpoint (DFS): Positive
        • DFS HR 0.75; one-sided p=0.017
        • 5-yr DFS: 
          • 71.7% (PORT+cetuximab) vs 63.6% (PORT)
      • Toxicity:
        • Acute grade 3 to 4: 
          • 70.3% (PORT+cetuximab) vs 39.7% (PORT); p<0.0001:
        • Late grade 3 to 4: 
          • 33.2% vs 29.0%, p=0.31 (no significant increase)
        • No grade-5 events NRG Oncology
      • Quality of life: 
        • A dedicated RTOG-0920 QoL analysis was presented at ASCO 2025:
          • Aligns with the toxicity profile (no long-term penalty reported in the abstract listing). ASC Publications+1
  • Interpretation (how to use this):
    • For HPV-negative, intermediate-risk patients who are not ideal candidates for high-dose cisplatin (remember cisplatin is reserved for high-risk ENE+ / positive-margin per RTOG 9501/EORTC 22931 era):
      • Adding cetuximab to PORT is a reasonable option to improve DFS without increasing late toxicity:
        • With trade-off of substantially higher acute toxicity
        • OS was not improved PubMed+1
        • HPV-positive:
          • No signal of benefit:
            • Do not extrapolate a DFS advantage here. PubMed
    • Sites: 
      • Data are particularly representative for oral cavity primaries (largest stratum) Red Journal
  • Practical selection checklist (tumor board quick hits):
    • Use PORT + cetuximab consideration when ALL are true:
      • HPV-negative HNSCC (oral cavity / oropharynx / larynx)
      • Intermediate-risk features as per protocol list above
      • No ENE or positive margins:
        • Those are high-risk → cisplatin-based CRT
      • Patient not a good candidate for cisplatin (comorbidities, renal / hearing issues)
      • Accepts higher acute toxicity risk and closer supportive care during RT ozarkscancerresearch.org+2PubMed+2
  • Key trial specs (at a glance):
    • NCT00956007; Opened Nov 2009, closed Mar 2018; n=577 eligible. NRG Oncology+1
    • IMRT mandatory; p16 testing required for oropharynx; EGFR IHC collected (stratification/analysis). ozarkscancerresearch.org
  • Citation anchors:
    • Machtay M, et al. JCO 2025;43(12):1474–1487. Epub Jan 22, 2025. (Primary publication.) PubMed
    • NRG Oncology press summary with HRs, 5-yr estimates, and toxicity breakdown. NRG Oncology
    • Protocol (2016) schema/eligibility for exact intermediate-risk feature definitions and cetuximab dosing. ozarkscancerresearch.org
    • Additional baseline composition (oral cavity %, EGFR high) from earlier abstract. Red Journal
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Published by Rodrigo Arrangoiz MS, MD, FACS, FSSO

My name is Rodrigo Arrangoiz I am a breast surgeon/ thyroid surgeon / parathyroid surgeon / head and neck surgeon / surgical oncologist that works at Center for Advanced Surgical Oncology in Miami, Florida. I was trained as a surgeon at Michigan State University from (2005 to 2010) where I was a chief resident in 2010. My surgical oncology and head and neck training was performed at the Fox Chase Cancer Center in Philadelphia from 2010 to 2012. At the same time I underwent a masters in science (Clinical research for health professionals) at the University of Drexel. Through the International Federation of Head and Neck Societies / Memorial Sloan Kettering Cancer Center I performed a two year head and neck surgery and oncology / endocrine fellowship that ended in 2016. Mi nombre es Rodrigo Arrangoiz, soy cirujano oncólogo / cirujano de tumores de cabeza y cuello / cirujano endocrino que trabaja Center for Advanced Surgical Oncology en Miami, Florida. Fui entrenado como cirujano en Michigan State University (2005 a 2010 ) donde fui jefe de residentes en 2010. Mi formación en oncología quirúrgica y e n tumores de cabeza y cuello se realizó en el Fox Chase Cancer Center en Filadelfia de 2010 a 2012. Al mismo tiempo, me sometí a una maestría en ciencias (investigación clínica para profesionales de la salud) en la Universidad de Drexel. A través de la Federación Internacional de Sociedades de Cabeza y Cuello / Memorial Sloan Kettering Cancer Center realicé una sub especialidad en cirugía de cabeza y cuello / cirugia endocrina de dos años que terminó en 2016.

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