A randomized study with cisplatinum concomitant with standard or adaptive high dose radiotherapy for advanced head and neck cancer.

Phase 3

Completed

• Conditions: head and neck cancer; Oropharyngeal cancer; 10038666; 10046304

• Registration Number: NL-OMON45016
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 135

Inclusion Criteria

- Squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx;- Stage III-IV, T3-4, Nx M0;- Age 18 to 70 yrs;- eligible for chemoradiation treatment with adequat renal and hepatic function;- informed consent

Exclusion Criteria

- Inability to undergo any one of the treatment arms;- Laryngeal cancer;- Known active symptomatic infections;- Prior surgery, radiotherapy or chemotherapy for this tumour

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints<br /><br>a. Loco-regional recurrence-free interval at two years<br /><br>b. Toxicity at two years<br /><br>c. Evaluation of predictive biomarkers</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints<br /><br>a. Quality of life during and after treatment<br /><br>b. Swallowing function preservation at one year<br /><br>c. Progression Free Survival<br /><br>d. Overall Survival</p><br>