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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02778191

Enrollment

413

Registered

2016-05-19

Start date

2016-02-29

Completion date

2017-03-31

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and neck squamous cell carcinoma, cisplatin, carboplatin, 5-fluorouracil

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.

Interventions

DRUGcisplatin

100 mg/m2 day 1, 22 and 43

DRUGcarboplatin

carboplatin 300-350 mg/m2 day 1, 22 and 43

DRUG5-FU

5-FU 600 mg/m2 days 1-4, 22-25 and 43-46

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Progression free survival	1 year	—
Distant metastases	1 year	—
Overall survival	1 year	—
Late toxicity	1 year	retrospective data collection
Quality of life	1 year	EORTC questionnaire QLQ C30
Grade 3-4 acute toxicity	1 year	retrospective data collection

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026