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

U

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Head and Neck Squamous Cell Carcinoma

Treatments

Drug: 5-FU
Drug: cisplatin
Drug: carboplatin

Study type

Observational

Funder types

Other

Identifiers

NCT02778191
201501099

Details and patient eligibility

About

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.

Full 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.

Enrollment

413 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

413 participants in 2 patient groups

Concomitant cisplatin
Description:
Patients treated with concomitant cisplatin
Treatment:
Drug: cisplatin
Carboplatin plus 5-FU
Description:
Patients treated with carboplatin plus 5-FU
Treatment:
Drug: carboplatin
Drug: 5-FU

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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