Adaptive Dose-Escalated Multi-modality Image-guided RadiothErapy (ADMIRE) for head and neck cancer by twice re-imaging, re-delineation and re-planning during the course of radiotherapy

Completed

• Conditions: Head and neck cancer; 10027655

• Registration Number: NL-OMON47484
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Histologic biopsy confirmed squamous cell carcinoma of the oral cavity, HPV-negative oropharynx, hypopharynx or larynx
T2-T4
Scheduled for radiotherapy or radiotherapy with cisplatin or cetuximab

Exclusion Criteria

GFR<30
Other neoplasms with metastases in the previous 3 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The feasibility of the adaptive radiotherapy schedule will be rejected in case<br /><br>of:<br /><br>- Occurrence of intolerable radiation-induced acute toxicities.<br /><br>- The inability to implement 80% of the adaptive treatment plans within 2 days<br /><br>from the intended starting day (day 13 and day 23 of treatment).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To examine the toxicity of the adaptive radiotherapy scheme according to the<br /><br>CTCAE v4.0 scoring system<br /><br>The locoregional tumor control<br /><br>The mean value of the different imaging modalities within the tumor will be<br /><br>measured at baseline and during week 2 and 4. Using these, the relative<br /><br>response will be calculated for the following modalities:<br /><br>- FDG-PET: decrease of the SUV-value</p><br>