OncoMatch/Clinical Trials/NCT02734537
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
Is NCT02734537 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cisplatin for head and neck squamous cell carcinoma.
Treatment: Cisplatin — This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A loss of p16 protein expression by IHC (negative)
For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)
Required: TP53 mutation
central determination of p53 mutation status of the surgical tumor tissue has been completed
Disease stage
Required: Stage III, IVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — curative intent, total resection of the primary tumor
Patient has undergone total resection of the primary tumor with curative intent
Cannot have received: chemotherapy
Exception: within two years of surgical resection of the primary tumor
patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor
Cannot have received: investigational therapy
Exception: within two years of surgical resection of the primary tumor
patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor
Cannot have received: radiation therapy
Exception: previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mm^3 and platelets ≥ 100,000/mm^3 within 4 weeks prior to randomization
Kidney function
Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization
Liver function
Total bilirubin ≤ the upper limit of normal (ULN) within 4 weeks prior to randomization
Absolute neutrophil count ≥ 1,500/mm^3 within 4 weeks prior to randomization; Platelets ≥ 100,000/mm^3 within 4 weeks prior to randomization; Total bilirubin ≤ the upper limit of normal (ULN) within 4 weeks prior to randomization; Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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 qualify