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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778191
• Other study ID #: 201501099
• Status: Completed
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• cisplatin
100 mg/m2 day 1, 22 and 43
• carboplatin
carboplatin 300-350 mg/m2 day 1, 22 and 43
• 5-FU
5-FU 600 mg/m2 days 1-4, 22-25 and 43-46

Locations

Country	Name	City	State
Netherlands	VUmc	Amsterdam
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemotherapy completion rate	The percentage of patients who completed 3 cycles of chemotherapy between both cohorts will be compared.	1 year
Secondary	Overall survival		1 year
Secondary	Progression free survival		1 year
Secondary	Distant metastases		1 year
Secondary	Grade 3-4 acute toxicity	retrospective data collection	1 year
Secondary	Late toxicity	retrospective data collection	1 year
Secondary	Quality of life	EORTC questionnaire QLQ C30	1 year
Secondary	Quality of life	EORTC questionnaire HN35	1 year