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

NCT02778191 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 413

Last updated 2024-05-06

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • S. Oosting, MD, PhD · UMCG

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02778191 on ClinicalTrials.gov