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 (Jun 2026). This Phase 2 trial studies Carboplatin for head and neck cancer.
Treatment: Carboplatin — The 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
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
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 →Frequently asked questions
Is NCT05544136 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CDKN2A?
Yes, CDKN2A P16 IHC negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage N2C is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages