Conditions: Neoplasms, Head and Neck
Keywords: Neck Cancer Locally advanced head and neck cancer locally advanced Head and Neck cancer lapatinib EGFR/ErbB2 inhibitor Head Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 67
Healthy volunteers: no

Brief summary:
This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.

Detailed description:

Arms:
arm 1: 1500mg lapatinib orally daily arm 2: orally daily

Interventions: intervention 1: Lapatinib oral tablets intervention 2: radiotherapy intervention 3: cisplatin chemotherapy
Intervention descriptions: intervention 1: Lapatinib is administered orally once daily. intervention 2: Radiotherapy is given either as conventional fractionation using Two-dimensional (2D) or conformal techniques, or as Intensity Modulated Radiation Therapy (IMRT). Radiation therapy will be standardised throughout the study. Radiation therapy is given only once daily, with a dose/fraction not exceeding 2.5Gy, to a total dose of 65 Gy (IMRT) or 70 Gy (2D or 3D RT) to the gross site of disease . intervention 3: Cisplatin is administered intravenously at a dose of 100mg/m2 on days 1, 22 and 43 of radiotherapy (approximately Study Days 8, 29 and 50).

Protocol document: