Cetuximab & Concomitant-Boost Accelerated RT in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.
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ClinicalTrials.gov Identifier: NCT00251381
Recruitment Status : Unknown
Verified October 2006 by Trial Form Support S.L.. Recruitment status was: Recruiting
The purpose of this study is to determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.
Condition or disease
To determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.
To determine the 2 and 3 year rate of locoregional disease control.
To evaluate the safety and toxicity of the combination of cetuximab and concomitant-boost accelerated radiotherapy followed by 12 weeks of complementary treatment with cetuximab. Both acute and chronic toxicity will be assessed.
To determine specific disease-free survival, event-free survival, disease-specific survival and overall survival
To determine acute and late toxicity
To determine EGFR, p53, Ki67, and evaluate its value as a prognostic factor.
Open Label Randomized Phase II, Multicentre, Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Concomitant-Boost Accelerated Radiotherapy Followed or Not by a Complementary Treatment With Cetuximab in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.
Study Start Date :
Study Completion Date :
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1-year rate of Locoregional Disease Control in the experimental arm, deffined as complete and persistent disappearance of disease in the primary tumour and regional lymph nodes.
Secondary Outcome Measures :
Toxicity and safety of treatment will be evaluated using the Common Toxicity Criteria (CTC) of the NCI, version 3.0.; and late toxicity from radiotherapy, using RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Written informed consent.
Aged between 18 and 80, inclusive.
Karnofsky functional status >= 70% at the time of enrolment in study.
Life expectancy of more than 3 months.
Histologically confirmed diagnosis of oropharyngeal squamous cell carcinoma: base of tongue, vallecula, tonsil and tonsillar fossa and pillars, glossotonsillar sulcus, inferior surface of the soft palate, uvula and lateral and posterior oropharyngeal wall.
Stage III or IV with no evidence of distant metastasis (IVA or IV B)
Patients in medical conditions to receive a radical concomitant-boost accelerated radiotherapy treatment.