Conditions: Head and Neck Cancer
Keywords: Cetuximab Erbitux locally advanced head neck cancer neoplasms squamous carcinoma lymphoepithelioma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 110
Healthy volunteers: no

Brief summary:
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

Detailed description:

Arms:
arm 1: Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks. arm 2: Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.

Interventions: intervention 1: Cetuximab intervention 2: 5-FU intervention 3: Hydroxyurea intervention 4: Twice-daily radiation intervention 5: Cisplatin intervention 6: Accelerated fraction radiotherapy with concomitant boost
Intervention descriptions: intervention 1: 250mg/m2(day 1, weekly x 10); intervention 2: 600 mg/m2/day; days 0-5 (120 h total) every other week x 5 intervention 3: 500 mg PO BID, days 0-5 every other week x 5 intervention 4: 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks) intervention 5: 100 mg/m2, week 1 and 4 on day 1 (or 2) intervention 6: 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.

Protocol document: