NCT05943119

Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Centre Francois Baclesse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The patient is randomized to one of the following groups: * Experimental group: Radiotherapy in painting dose on histoscannographic mapping * Control group: standard pan-sinus radiotherapy

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
RADIATION	Radiotherapy in painting dose on histoscannographic mapping	The target volumes to be delineated are as follows: * High-risk CTV (Clinical Target Volume), corresponding to all initially invaded areas, as identified by comparison between the operative report and the anatomo-pathological report (ideally with histo-surgical mapping). * Low-risk CTV, corresponding to naso-sinusal structures not initially invaded but at risk of recurrence, and located close to the high-risk target volume, including at least 5 mm around the high-risk volume and excluding non-risk areas (muscle, bone).
RADIATION	Standard pan-sinusal Radiotherapy	The target volumes to be delineated are as follows: * High-risk CTV, including the entire post-operative cavity, * Low-risk CTV, adapted from the recommendations described by Lapeyre (Cancer/Radiotherapy 2005), and including at least 5 mm around the high-risk volume, excluding non-risk areas (muscle, bone).

Timeline

• Start date: 2024-03-11
• Primary completion: 2028-01-01
• Completion: 2029-03-01
• First posted: 2023-07-13
• Last updated: 2025-07-28

Locations

3 sites across 1 country: France