A Phase III Study Of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab In Patients With Locally Advanced Stage III And IV Squamous Cell Carcinoma Of The Head And Neck.
Complexity Level: 1
Eligibility: Patients with histologically confirmed squamous cell carcinoma of the head and neck of the oral cavity, oropharynx, larynx or hypopharynx which is locally advanced as defined by TanyN+M0 or T3-4N0M0.
Objectives: The primary objective is progression free survival. The secondary objectives include: overall survival, local progression free survival, regional progression free survival, distant metastasis, acute and late adverse events, quality of life, swallowing related quality of life, functional swallowing outcome (selected centres), significance of tissue and blood biomarkers, and health economics.
NCT Registration ID (from clinicaltrials.gov): NCT00820248
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 18, 2008 Closing Date: November 07, 2011
Chair: (Canada) Dr. John Waldron, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-6522, (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911