NCT02778191

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 413 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-05-19
• Last updated: 2024-05-06

Locations

2 sites across 1 country: Netherlands