AJCC Stage III/IV, Head and Neck Neoplasms
Conditions
Keywords
locally advanced,, unresectable,, head and neck squamous cell carcinoma,, stage III/IV
Brief summary
To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment
Detailed description
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.
Interventions
OTHERChemoradiation plus Cetuximab
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)
OTHERChemoradiation
Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2
Sponsors
Theagenio Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine safety and toxicity of combination | Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months | Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival time | Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months | 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. |
| Progression-free survival time | Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months | 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. |
| Response | Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months | 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. |
Countries
Greece
Outcome results
None listed