Trial Information

CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment Followed by 6 Weeks of Cetuximab+RT Post Surgery in Locally Advanced Squamous Cell Carcinoma of the Tongue ; A NEW PARADIGM OF TREATMENT

This non-randomized, open-label, single center phase II study, will determine if patients
with advanced oral tongue cancer that are treated with induction doses of cetuximab followed
by treatment with radiation therapy concurrently with cetuximab and cisplatin (when
indicated by positive margins or extra-capsular extension), will have improved PFS and
improved survival and feasible toxicity, compared with patients treated in previous clinical
trials (RTOG 9501 and EORTC 22931) with standard therapy: radiotherapy of 60 Gy with or
without a 6-Gy boost (RTOG 9501) or 66 Gy (EORTC 22931) delivered through a conventional
fractionation regimen of five once-daily sessions per week, and cisplatin in a dose of 100
mg/m2 on days 1, 22, and 43.. Twenty five patients will be recruited. Cetuximab treatment
will be started (day 0) with 400 mg/m2 followed by two doses of 250 mg/m2 (once weekly on
day 7 and 14). Surgery will be performed on day 31 followed by treatment with radiation
therapy concurrently with cetuximab (250 mg/m2, once weekly) and cisplatin 35 mg/m2 (days
70-112; when indicated by positive margins or lymph nodes with extra-capsular extension).
PET-CT and biopsies will be performed before starting with cetuximab, just before surgery
and after chemo-cetuximab-RT to determine efficacy of treatment, and to compare the
diagnostic properties of the PET-CT with that of the biopsies. The changes, before and after
treatment with cetuximab, of protein levels in saliva, and tumor tissue and of microRNA
levels in tumor tissue will be studied and correlated with PFS. The quality of life will be
assessed. Data from clinical trials RTOG 9501 and EORTC 22931 will be used as historical
controls.