De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas

In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+) postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and / or residual tumor (R1-Status) after resection. Oropharyngeal cancer caused by HPV (human papillomavirus 16) is a distinct subgroup with a known sensitivity to radiotherapy (RTx) or radiochemotherapy (RCTx).

Trial Details

NCT ID
NCT03396718
Phase
NA
Sponsor
Technische Universität Dresden
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • De-escalation radio(chemo)therapy - Level 1
  • De-escalation radio(chemo)therapy - Level 2
  • Standard radio(chemotherapy)
Locations (sample)
  • Tübingen, Baden-Wurttemberg, Germany|48.52266,9.05222
  • Essen, North Rhine-Westphalia, Germany|51.45657,7.01228
  • Dresden, Saxony, Germany|51.05089,13.73832
  • Berlin, Germany|52.52437,13.41053
  • Frankfurt am Main, Germany|50.11552,8.68417

Key Eligibility Criteria

  • Condition after surgical removal of a squamous cell carcinoma of the oropharynx and adequate lymph node dissection
  • Indication for adjuvant radiotherapy or radiochemotherapy in the interdisciplinary tumor board
  • Good general state (ECOG performance status 0 or 1)
  • Adequate compliance to ensure closely follow-up

For full eligibility, visit ClinicalTrials.gov.

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