Status: Closed
Activation Date: 2008DEC18
Closing Date: 2011NOV07
Phase: III
Description: 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.
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.
Objective: 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.
Participation: Open to member centres
Lay Description: The purpose of this study is to compare the effects of accelerated radiotherapy with the drug panitumumab compared to standard radiotherapy with cisplatin chemotherapy. This research is being done because panitumumab and accelerated radiotherapy are promising treatments for head and neck cancer. We do not know if this may be better, the same, or worse at controlling the cancer than standard treatment. Panitumumab is a type of antibody therapy which acts against a protein on tumour cells called the epidermal growth factor receptor. Panitumumab belongs to a class of drugs call "EGFR inhibitors". Other EGFR inhibitors similar to panitumumab have been shown to slow the growth of head and neck cancer when combined with radiotherapy. Panitumumab has been shown to slow the growth of advanced colon cancer.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| HEAD AND NECK | HN6 | 320 | 142 | 89 | 208 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| HEAD AND NECK | HN6 | 320 | 2 | 16 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| HEAD AND NECK | HN6 | 320 | 1 | 263 | 0 | 0 | 262 | 265 | 0 | 0 |