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NCT Number: NCT02778191

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

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VUmc, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

100 mg/m2 day 1, 22 and 43

carboplatin

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

Primary outcomes

  1. Chemotherapy completion rate

    Time frame: 1 year

    The percentage of patients who completed 3 cycles of chemotherapy between both cohorts will be compared.

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

  2. Progression free survival

    Time frame: 1 year

  3. Distant metastases

    Time frame: 1 year

  4. Grade 3-4 acute toxicity

    Time frame: 1 year

    retrospective data collection

  5. Late toxicity

    Time frame: 1 year

    retrospective data collection

  6. Quality of life

    Time frame: 1 year

    EORTC questionnaire QLQ C30

  7. Quality of life

    Time frame: 1 year

    EORTC questionnaire HN35

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Amsterdam UMC, location VUmc

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 19, 2016
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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