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

NCT ID: NCT02778191

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

413 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-03-31

Brief Summary

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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

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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

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Head and Neck Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Concomitant cisplatin

Patients treated with concomitant cisplatin

cisplatin

Intervention Type DRUG

100 mg/m2 day 1, 22 and 43

Carboplatin plus 5-FU

Patients treated with carboplatin plus 5-FU

carboplatin

Intervention Type DRUG

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

5-FU

Intervention Type DRUG

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

Interventions

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cisplatin

100 mg/m2 day 1, 22 and 43

Intervention Type DRUG

carboplatin

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

Intervention Type DRUG

5-FU

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S. Oosting, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

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VUmc

Amsterdam, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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201501099

Identifier Type: -

Identifier Source: org_study_id

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