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Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma (NCT02778191)

VU University Medical Center
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.
  • Drug: cisplatin
    100 mg/m2 day 1, 22 and 43
    • Drug: carboplatin
      carboplatin 300-350 mg/m2 day 1, 22 and 43
      • Drug: 5-FU
        5-FU 600 mg/m2 days 1-4, 22-25 and 43-46
        Ages eligible for Study
        18 Years to 70 Years
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        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
        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.

        2 locations

        Netherlands (2)
        • VUmc
          Not specified
          Amsterdam, Netherlands
        • University Medical Center Groningen
          Not specified
          Groningen, Netherlands, 9713 GZ
        Status:
        completed
        Type:
        Observational
        Phase:
        -
        Start:
        31 January, 2016
        Updated:
        15 May, 2017
        Participants:
        413
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