Multiinstitutional Open Label Randomized Phase II Study Comparing Cetuximab and Radiotherapy Versus Cisplatin and Radiotherapy as Firstline Treatment for Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-NHSCC)
PRIMARY OBJECTIVES:
Evaluation and comparison of the compliance of the two treatments;
SECONDARY OBJECTIVES:
Evaluation and comparison of the grade and incidence of acute toxicity; Evaluation and
comparison of local control; Evaluation and comparison of event free survival (both local
control and distant metastases); Evaluation and comparison of cause specific and overall
survival.
INCLUSION/EXCLUSION CRITERIA
- Histologically confirmed squamous cell carcinoma (biopsy obtained from the tumor and/or
from its lymphnodal metastases) originating from oral cavity, oropharynx, hypopharinx,
supraglottic larynx;
- Locally advanced disease, defined by one of the following criteria: every T, N+, M0 (
T1, N1 cases excluded); T3-4, N0, M0;
- Not a nasopharynx, paranasal sinuses, salivary glands tumor;
- General conditions and concomitant diseases not considered a contraindication for
chemotherapy or curative radiotherapy;
- No other surgical, chemotherapeutic or radiotherapic treatments for ENT region tumors
or for tumors of other anatomical sites (with the exception of non-melanoma cutaneous
tumors and of the carcinoma in situ of the uterine cervix and of other solid tumors
whose primary treatment has been completed more than 3 years before the accrual in this
study and never relapsed since primary treatment (the patient having been since then
continuously disease- free);
- Availability for follow-up;
- Signed informed consent;
- An interval of maximum 3 weeks between staging procedures for local disease and
randomization
- An interval of maximum 2 weeks between randomization and the onset of the treatment
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compliance
Evaluation and comparison of the compliance of the two treatments arms
weekly during treatment
No
Stefano M Magrini, Prof
Study Chair
Radiotherapy Dept., Prato Hospital and Brescia University
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
eudract 2010-021552-26
NCT01216020
October 2010
October 2016
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