Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: cisplatin
* Drug: carboplatin
* Drug: 5-FU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage III-IV LA-HNSCC of hypopharynx, oropharynx, larynx, oral cavity Primary treatment with concomitant chemoradiotherapy consisting of three-weekly cisplatin or carboplatin plus 5-FU Age ≤ 70 years No previous treatment for head and neck cancer No distant metastases Exclusion Criteria: Previous treatment for head and neck cancer Distant metastases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Concomitant cisplatin<br>Patients treated with concomitant cisplatin | Drug: cisplatin<br>* 100 mg/m2 day 1, 22 and 43<br>|
| Carboplatin plus 5-FU<br>Patients treated with carboplatin plus 5-FU | Drug: carboplatin<br>* carboplatin 300-350 mg/m2 day 1, 22 and 43<br>Drug: 5-FU<br>* 5-FU 600 mg/m2 days 1-4, 22-25 and 43-46<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 
| Progression free survival |  | 1 year | 
| Distant metastases |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck squamous cell carcinoma, cisplatin, carboplatin, 5-fluorouracil