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

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: carboplatin; Drug: cisplatin; Drug: 5-FU

• Registration Number: NCT02778191
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Study Timeline

• Study First Submitted: 2015-12-15
• Study Start: 2016-02
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carboplatin plus 5-FU	carboplatin	Patients treated with carboplatin plus 5-FU
Concomitant cisplatin	cisplatin	Patients treated with concomitant cisplatin
Carboplatin plus 5-FU	5-FU	Patients treated with carboplatin plus 5-FU

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Distant metastases	1 year
Grade 3-4 acute toxicity	1 year	retrospective data collection
Progression free survival	1 year
Overall survival	1 year
Quality of life	1 year	EORTC questionnaire HN35
Late toxicity	1 year	retrospective data collection

Trial Locations

Locations (2)

VUmc; 🇳🇱 Amsterdam, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands