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RECRUITING
NCT05943119
PHASE2

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

Sponsor: Centre Francois Baclesse

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2024-03-11

Completion Date

2029-03

Last Updated

2025-07-28

Healthy Volunteers

No

Conditions

Interventions

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).

Locations (3)

Centre Francois Baclesse

Caen, France

CHU CAEN

Caen, France

Centre Oscar Lambret

Lille, France