About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients >18 years of age
Patient with a histologically confirmed malignant tumor of the sinuses, any histological type except melanoma, lymphoma, mesenchymal tumors (sarcoma)
Patient treated by endoscopic sinonasal surgery with histosurgical mapping within 2 months prior to radiotherapy
Indication for radiotherapy treatment (photontherapy or protontherapy), without neoadjuvant chemotherapy (concomitant chemotherapy is permitted)
Disqualifiers
Patient with not operated in place tumor
Patient with distant metastases
Patient treated with neoadjuvant chemotherapy
Pregnant or breast-feeding woman or absence of contraception during genital activity
Trial design
Parallel
Treatments tested in this trial
Radiotherapy in painting dose on histoscannographic mapping
RadiationThe 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).
Standard pan-sinusal Radiotherapy
RadiationThe 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).
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Tumor response
Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
Tumor response
Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
Tumor response
Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
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)
Other outcomes
Assessment of molecular and cellular changes following radiation therapy in order to study potential toxicities affecting the mucous membranes and the surface of flaps, using an innovative, non-invasive surface analysis method.
Change in the molecular profile with spidermass technology of nasal swabs and plasma
Sponsors and contacts
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