RecruitingPhase IIEN originalHead and neck cancerEarly / localized

The Minimalist Trial-2

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (\>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy. However, patients treated with surgery followed by postoperative adjuvant chemotherapy and radiation therapy (POA(C)RT) still experience substantial morbidity. In this highly curable disease, current clinical research interest is focused on investigation of de-escalated therapy, with the goal to reduce treatment-related adverse events (AEs) while maintaining a low recurrence rate. In this study, patients with HPV-related OPSCC will undergo resection of the primary tumor site and involved/at-risk regional neck nodes. Based on the pathology report, patients will be assigned to: * Arm 1 (de-POACRT-42 Gy) * Arm 2A (de-POART-42 Gy) * Arm 2B (de-POART-37.8 Gy) * Arm 2C (de-POACRT-30 Gy). All patients with high-risk pathology will be assigned to Arm 1 whereas patients with intermediate-risk pathology will be randomized (1:1:1) to Arm 2A, Arm 2B, or Arm 2C. Patients with highest-risk pathology and low-risk pathology will be removed from the trial after surgery and will be advised to pursue standard of care options.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony rak gardła związany z wirusem HPV, stadium 1-2
  • Планируется chirurgiczne usunięcie guza dostępem przez usta
  • Planowane usunięcie węzłów chłonnych na szyi
  • Ogólny stan zdrowia pozwalający na uczestnictwo (ECOG 0-2)
  • Prawidłowa funkcja nerek, białych krwinek i płytek krwi
  • Wiek co najmniej 18 lat
  • Zgoda na stosowanie antykoncepcji (dla kobiet w wieku rozrodczym i mężczyzn)
  • Podpisana świadoma zgoda na uczestnictwo w badaniu

✗ Disqualifies

  • Bardzo małe guzy (T1N0M0 lub T2N0M0)
  • Wcześniejsza radioterapia szyi lub głowy
  • Planowana rozległa rekonstrukcja po operacji
  • Ciężka choroba wątroby (marskość)
  • Wcześniejszy nowotwór w ciągu ostatnich 2 lat
  • Uczestnictwo w innym eksperymentalnym badaniu
  • Poważne problemy zdrowotne lub psychiczne uniemożliwiające uczestnictwo
  • Ciąża lub karmienie piersią

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 24, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (3)

Washington University School of Medicine

St Louis, United States

Sanford Roger Maris Cancer Center

Fargo, United States

Sanford Cancer Center

Sioux Falls, United States

Trial contact

Douglas Adkins, M.D.

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/26/2026.

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