NRG-HN016

Open to Accrual

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Radiotherapy with Concurrent Cetuximab vs. Carboplatin and Paclitaxel in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin: A Pragmatic Phase III Randomized Trial (CONCISE)

Principal Investigator

Loren K. Mell

Status

Open to Accrual

Date Opened To Accrual

June 10, 2026


Disease Site

Head and Neck [HN] Head and Neck

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine whether radiation therapy (RT) and concurrent carboplatin and paclitaxel (RT+CP) improves progression-free survival(PFS) compared to RT with concurrent cetuximab (RT +Cetux) in patients with locoregionally advanced head and neck cancer (HNC) who have a contraindication to cisplatin.

Patient Population

Patients with pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity with a contraindication to cisplatin.

Target Accrual

454

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Other

HN016 Comogram

Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.