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| Name | Class |
|---|---|
| Amsterdam UMC, location VUmc | OTHER |
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Concomitant chemoradiotherapy improves overall survival in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin 100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative but both chemotherapy regimens have not been compared prospectively. The aim of this study is to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC treated with concomitant cisplatin and carboplatin plus 5-FU.
This is a retrospective comparison of patients with LA-HNSCC treated with chemoradiotherapy at 2 tertiary care centers in the Netherlands (UMCG and VUmc), where one center routinely gives carboplatin plus 5FU (UMCG) and the other center (VUmc) uses high dose cisplatin as standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concomitant cisplatin | Patients treated with concomitant cisplatin |
| |
| Carboplatin plus 5-FU | Patients treated with carboplatin plus 5-FU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | 100 mg/m2 day 1, 22 and 43 |
| |
| carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy completion rate | The percentage of patients who completed 3 cycles of chemotherapy between both cohorts will be compared. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 1 year | |
| Progression free survival | 1 year | |
| Distant metastases |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with locally advanced head and neck squamous cell carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| S. Oosting, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VUmc | Amsterdam | Netherlands | ||||
| University Medical Center Groningen |
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| Drug |
carboplatin 300-350 mg/m2 day 1, 22 and 43 |
|
| 5-FU | Drug | 5-FU 600 mg/m2 days 1-4, 22-25 and 43-46 |
|
| 1 year |
| Grade 3-4 acute toxicity | retrospective data collection | 1 year |
| Late toxicity | retrospective data collection | 1 year |
| Quality of life | EORTC questionnaire QLQ C30 | 1 year |
| Quality of life | EORTC questionnaire HN35 | 1 year |
| Groningen |
| 9713 GZ |
| Netherlands |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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