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

Sponsor:

NRG

Sponsor Study ID:

NRG-HN016

CTO #:

104399

NCT Number:

NCT07441681

Phase:

III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Larynx; Lip, Oral Cavity and Pharynx

Study Objectives:

Progression free survival (PFS) [Time Frame: From randomization until locoregional failure, distant failure, or death due to any cause, up to 8 years] The PFS rates for each treatment arm will be estimated in the overall sample and within each p16 subgroup using the Kaplan-Meier method. Estimates of the median PFS and 2-year PFS rates will be obtained with 90% confidence intervals. The comparison of PFS distributions between each treatment arm will be performed using a one-sided stratified log-rank test (stratified by the randomization stratification factors). As additional analysis of treatment effect, multivariable analysis will be performed using a Cox proportional hazards model, where the stratification factors, and relevant patient and tumor characteristics are included (as measured by the model's Bayesian Information Criterion [BIC]). Hazard ratios and their respective 90% confidence intervals will be provided.

eConsent:

Not available

Study Documents:

Open Study Documents
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