Phase I study of radiotherapy dose escalation on the 18F-FDG-PET avid region of the primary tumor in locally advanced oropharynx and oral cavity tumors eligible for concurrent chemoradiation.

• Conditions: Cancer of the mouth and throat; oropharynx/oral cavity carcinoma`s; 10017991

• Registration Number: NL-OMON33780
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• Histology proven squamous cell carcinoma of the oral cavity and oropharynx.
• TNM stage III/IV, functional inoperable, > 30 cc primary tumor volume
• Eligible and scheduled for concurrent cisplatin-based chemoradiation with curative intent (RADPLAT, cisplatinum 100mg/m² w1,4 and 7)

Exclusion Criteria

Radiotherapy hypersensitivity
Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Primary end-point:<br /><br>Maximum tolerated dose (MTD) is defined as the dose where dose limiting<br /><br>toxicity exceeds 10%<br /><br>The recommended phase II dose (RPTD) is one dose level below the (MTD)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Secondary end-points:<br /><br>- CTCAE toxicity scales v 3.0 for acute toxicity (within 3 months after end of<br /><br>treatment) and late toxicity (after minimum 6 months after end of treatment)<br /><br>- Loco-regional control, overall and cause specific survival and cause of death<br /><br>after 2 years<br /><br>- Localisation of all recurrences with respect to the different dose levels<br /><br>administered (PTV57.75, PTV70 nodes, PTV70 primary outside the PTV-PET,<br /><br>PTV-PET).<br /><br>- Dose to critical organs before and after replanning of the dose escalation<br /><br>volume. Volume change of PTV-PET after deformation.</p><br>