Phase II Study of Exclusive Intensity Modulated Radiation Therapy (IMRT) in Dose Painting for Sinus Carcinomas After Endoscopic Surgery

Study Overview
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Brief Summary
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The patient is randomized to one of the following groups: Experimental group: IMRT in painting dose on histoscannographic mapping Control group: standard pan-sinus IMRT

Official Title
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Phase II Study of Exclusive Intensity Modulated Radiation Therapy (IMRT) in Dose Painting for Sinus Carcinomas After Endoscopic Surgery

Conditions
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Tumor, Solid

Intervention / Treatment
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* Radiation: RCMI in painting dose on histoscannographic mapping
* Radiation: Standard pan-sinusal IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >18 years of age Patient with histologically confirmed nasosinus carcinoma Patient treated by endoscopic sinonasal surgery with histosurgical mapping within 2 months prior to radiotherapy Indication for radiotherapy treatment, without neoadjuvant chemotherapy (concomitant chemotherapy is permitted) Signature of informed consent prior to any specific study procedure Subject affiliated to a social security system Exclusion Criteria: Patient with not operated in place tumor Patient with distant metastases Patient treated with neoadjuvant chemotherapy Delay between surgery and radiotherapy greater than 8 weeks Other histologies (melanoma, sarcoma, lymphoma, etc.) Pregnant or breast-feeding woman or absence of contraception during genital activity History of any other malignant disease in the last 3 years, except basal cell skin cancer, carcinoma in situ or superficial bladder tumor. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no sign of recurrence for at least 3 years. Simultaneous participation in another therapeutic clinical trial Patients deprived of their liberty, under guardianship, under curatorship, or subject to a legal protection measure, or unable to express their consent. Patients unable to undergo trial monitoring for geographical, social or psychopathological reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group: IMRT in painting dose on histoscannographic mapping<br> | Radiation: RCMI in painting dose on histoscannographic mapping<br>* 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).<br>|
| Active Comparator: Control group: standard pan-sinus IMRT<br> | Radiation: Standard pan-sinusal IMRT<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence 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. | Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMRT, sinus, nasal, Mucosal toxicity