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To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy/Cisplatin(GroupA) | Active Comparator | Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2) |
|
| Radiotherapy/Cisplatin/Cetuximab(GroupB) | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoradiation plus Cetuximab | Other | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charalambos Andreadis, MD | Theagenio Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theagenio Cancer Hospital | Thessaloniki | 54007 | Greece |
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|
| Chemoradiation | Other | Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2 |
|
|
| 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 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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