Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck

Study Overview
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Brief Summary
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To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment

Detailed Description
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Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin (40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2, after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio). Groups will be matched age, sex, PS, and disease site.

Official Title
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Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

Conditions
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Head and Neck Neoplasms, AJCC Stage III/IV

Intervention / Treatment
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* Other: Chemoradiation plus Cetuximab
* Other: Chemoradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed HNSCC of oral cavity, larynx, oropharynx or hypopharynx; age of 18 years or more adequate liver (SGOT, SGPT, ALP ≤ 3x normal) kidneys (creatinine clearance ≥ 60ml/min heart (no arrythmias, no heart failure) and bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥ 100,000/μL) function ECOG performance status 0 or 1 and stage III or IVa to b with measurable lesions written informed consent Exclusion Criteria: prior radiotherapy chemotherapy concurrent active malignancies pregnancy breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiotherapy/Cisplatin(GroupA)<br>Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2) | Other: Chemoradiation<br>* Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2<br>* Other names: Platinol;|
| Experimental: Radiotherapy/Cisplatin/Cetuximab(GroupB)<br>Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation) | Other: Chemoradiation plus Cetuximab<br>* Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation)<br>* Other names: Erbitux;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine safety and toxicity of combination | Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system. | Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time | Time from first administration of trial treatment to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. | Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months | 
| Progression-free survival time | Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Patients without event are censored on the date of last tumor assessment. | Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months | 
| Response | Complete response (CR) is defined as the total disappearance of radiographic evidence of tumour. Partial response (PR) is defined as the ≥50% reduction in the product of the maximal bidimensional tumour diameters. Stable disease defined any change between +25% and -50% in tumour size, and progressive disease included any increase >25% from baseline or the appearance of any new lesion. We record tumour shrinkage and time to the development of disease progression according to the revised RECIST criteria, v.1.1. | Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced,, unresectable,, head and neck squamous cell carcinoma,, stage III/IV