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OncoMatch/Clinical Trials/NCT05544136

A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer

Is NCT05544136 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Carboplatin for head and neck cancer.

Phase 2RecruitingMemorial Sloan Kettering Cancer CenterNCT05544136Data as of May 2026

Treatment: CarboplatinThe purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: CDKN2A P16 IHC negative (negative)

If the primary site is oropharynx or unknown primary, P16 IHC must be negative.

Disease stage

Required: Stage N2C (AJCC 7th edition)

Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without evidence of distant metastasis

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiation therapy

Must not have received prior radiation therapy or chemotherapy for HNC.

Cannot have received: systemic chemotherapy

Exception: prior chemotherapy for a different non-H&N cancer is permissible

Must not have received prior radiation therapy or chemotherapy for HNC.

Cannot have received: chemotherapy or radiotherapy

Prior chemotherapy or radiotherapy within the last three years.

Lab requirements

Blood counts

WBC ≥ 2,000 cells/µL; ANC ≥ 1,000 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL (transfusion/intervention allowed to achieve Hgb ≥ 8.0 g/dL)

Kidney function

Serum creatinine < 1.5 mg/dL or creatinine clearance (CrCl) ≥ 50 mL/min; patients with serum creatinine > 1.5 mg/dL can be eligible for carboplatin-based chemotherapy with approval of co-PI

Liver function

Bilirubin < 2 mg/dL; AST or ALT < 3 x the upper limit of normal

Adequate hematologic, renal, and hepatic function within 30 days prior to registration, defined as: WBC ≥ 2,000 cells/µL; ANC ≥ 1,000 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL; Serum creatinine < 1.5 mg/dL or CrCl ≥ 50 mL/min; Bilirubin < 2 mg/dL; AST or ALT < 3 x ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) · Commack, New York
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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