Neoplasms

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Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Tongue Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antineoplastic Agents, Immunological

Drug administration ,Cetuximab(merck Serono )given neoadjuvant ,3 courses prior surgery followed by post operatve radiation and Cetuximab

cetuximab loading dosage 400mg/m2 followed by weekly 250mg/m2 2 weeks

Erbitux,merck serono

Aron Popovtzer, MD

Dror Limon, MD

Salomon Stemmer, MD

Rafael Feinmesser, MD

Thomas Spitzer, MD

Gideon Bachar, MD

To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501 and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease.

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.

CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT

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

To evaluate the role of downregulation of microRNAs according to the outcome of treatment

: To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501 and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease

To evaluate the frequency and severity of adverse events (AEs) for this treatment paradigm.

To evaluate the correlation between changes in expression levels of several biomarkers related to cell apoptosis and tumor progression: the endothelial growth factor receptor pathway, p53, human papilloma virus, BCL-2, BCL-X(L), and acid ceramidase - before and after treatment - with survival rates, PFS and response rates

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT	NCT01760811	Squamous Cell C...	Erbitux,merck s...	18 Years - 80 Years	Rabin Medical Center
CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT	NCT01760811	Squamous Cell C...	Erbitux,merck s...	18 Years - 80 Years	Rabin Medical Center

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