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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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).
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).
Centre Francois Baclesse
Caen, France
RECRUITINGCHU CAEN
Caen, France
NOT_YET_RECRUITINGCentre Oscar Lambret
Lille, France
NOT_YET_RECRUITINGOccurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities
Proportion of patients who do not develop radiation-induced mucosal, ocular, auditory, endocrine and/or nervous system toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.
Time frame: Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.
Tumor response
Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
Time frame: measured at 6 months after radiotherapy
Tumor response
Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
Time frame: measured at 12 months after radiotherapy
Tumor response
Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
Time frame: measured at 18 months after radiotherapy
Quality of life evaluation
Quality of life measured using the standardized self-administered questionnaire Quality of Life Questionnaire-Core 30 items QLQ-C30 score (min:0; max 100)
Time frame: from the start of the study and up to 18 months after radiotherapy
Description of acute and late clinical toxicities
Description of acute and late clinical toxicities according to CTCAE terminology, as well as specific medical questionnaires and self-report questionnaires from the NCI-PRO-CTCAE (covering visual, auditory, and cognitive symptoms, as well as fatigue).
Time frame: From the start of the study and up to 18 months after radiotherapy
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Dosimetry to healthy organs
Standard dosimetric criteria specific to each healthy organ (pituitary gland, optic nerves, eyes, lenses, middle and inner ears, nasal mucosa, etc.): maximum dose in 2% of the volume, average dose, etc., using NTCP (normal tissue complication probability) models on dose-volume histograms and 3D dose maps
Time frame: During radiotherapy
Tissue changes
Tissue changes observed on imaging and their correlation with the toxicities observed
Time frame: from the start of the study and up to 18 months after radiotherapy
Quality of life evaluation
Quality of life measured using the standardized self-administered questionnaire Head and Neck QLQ-HN43 score (min:0; max 100)
Time frame: from the start of the study and up to 18 months after radiotherapy
Quality of life evaluation
Quality of life measured using the standardized self-administered questionnaire : SNOT-22 (Sino-Nasal Outcome Test) (nasal symptoms score:min:0; max 5)
Time frame: from the start of the study and up to 18 months after radiotherapy