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

NCT02778191 | Completed

• 1 other identifier: 201501099
• Study Type: observational
• Target: 413
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Chemotherapy completion rate

  The percentage of patients who completed 3 cycles of chemotherapy between both cohorts will be compared.

  1 year

Secondary Outcomes (7)

• Overall survival

  1 year

• Progression free survival

  1 year

• Distant metastases

  1 year

• Grade 3-4 acute toxicity

  1 year

• Late toxicity

  1 year

Study Arms (2)

Concomitant cisplatin

Patients treated with concomitant cisplatin

Drug: cisplatin

Carboplatin plus 5-FU

Patients treated with carboplatin plus 5-FU

Drug: carboplatin; Drug: 5-FU

Interventions

cisplatin DRUG

100 mg/m2 day 1, 22 and 43

Concomitant cisplatin

carboplatin DRUG

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

Carboplatin plus 5-FU

5-FU DRUG

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

Carboplatin plus 5-FU

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with locally advanced head and neck squamous cell carcinoma

You may qualify if:

• 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

You may not qualify if:

• Previous treatment for head and neck cancer
• Distant metastases

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Amsterdam UMC, location VUmc: collaborator

Study Sites (2)

VUmc

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Carboplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• S. Oosting, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: May 19, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

NL (2)