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

May 3, 2024 updated by: University Medical Center Groningen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

413

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • VUMC
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with locally advanced head and neck squamous cell carcinoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Concomitant cisplatin
Patients treated with concomitant cisplatin
Drug: cisplatin
100 mg/m2 day 1, 22 and 43
Carboplatin plus 5-FU
Patients treated with carboplatin plus 5-FU
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
1 year
Progression free survival
Time Frame: 1 year
1 year
Distant metastases
Time Frame: 1 year
1 year
Grade 3-4 acute toxicity
Time Frame: 1 year
retrospective data collection
1 year
Late toxicity
Time Frame: 1 year
retrospective data collection
1 year
Quality of life
Time Frame: 1 year
EORTC questionnaire QLQ C30
1 year
Quality of life
Time Frame: 1 year
EORTC questionnaire HN35
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: S. Oosting, MD, PhD, UMCG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimated)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201501099

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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