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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 2017

Detailed Description

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Concomitant cisplatin
    • Patients treated with concomitant cisplatin
  • Carboplatin plus 5-FU
    • Patients treated with carboplatin plus 5-FU

Clinical Trial Outcome Measures

Primary Measures

  • Chemotherapy completion rate
    • Time Frame: 1 year
    • The percentage of patients who completed 3 cycles of chemotherapy between both cohorts will be compared.

Secondary Measures

  • Overall survival
    • Time Frame: 1 year
  • Progression free survival
    • Time Frame: 1 year
  • Distant metastases
    • Time Frame: 1 year
  • Grade 3-4 acute toxicity
    • Time Frame: 1 year
    • retrospective data collection
  • Late toxicity
    • Time Frame: 1 year
    • retrospective data collection
  • Quality of life
    • Time Frame: 1 year
    • EORTC questionnaire QLQ C30
  • Quality of life
    • Time Frame: 1 year
    • EORTC questionnaire HN35

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Center Groningen
  • Collaborator
    • VU University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: S.F. Oosting, Principal investigator – University Medical Center Groningen
  • Overall Official(s)
    • S. Oosting, MD, PhD, Principal Investigator, UMCG

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