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Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer

Recruiting
18 years of age
Both
Phase 2

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Overview

patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS>1 will recieve 3 cycles of induction immunochemotherapy with platinum, 5-FU and pembrolizumab followed by (chemo)radiation.

Description

patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS>1 will recieve 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.

Eligibility

Inclusion Criteria:

  • Squamous cell cancer of oropharynx (p16+: T0-3N3, T4N0-3, p16- : T3-4aN0-1, T1-4aN2-3), hypopharynx (T2-3N0-3, T1N+, T4aN0-3) or larynx III-IVa (T1-2N2-3, T3N2-3, T4aN0-3) , TNM8 staging classification;
  • Tumor is morphlogically confirmed;
  • CPS>1 (22C3 clone);
  • ECOG 0-2;
  • Age above 18 years;
  • Signed Informed consent form.

Exclusion Criteria:

  • Cancer of nasopharynx;
  • Non-squamous cell carcimomas or absense of morphological confirmation of squamous cell cancer;
  • Stages I or II;
  • ECOG>=3.

Study details

Neck Cancer

NCT05551767

City Clinical Oncology Hospital No 1

26 January 2024

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