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The patient is randomized to one of the following groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group: Radiotherapy in painting dose on histoscannographic mapping | Experimental |
| |
| Control group: standard pan-sinus Radiotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy in painting dose on histoscannographic mapping | Radiation | The target volumes to be delineated are as follows:
|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors) | measured at 6 months after radiotherapy |
| Tumor response | Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Before, during, and 3 months after radiation therapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent PATRON, MD | Contact | +33231063106 | patron-v@chu-caen.fr | |
| Juliette THARIAT, Prof | Contact | 33231455050 | j.thariat@baclesse.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Francois Baclesse | Recruiting | Caen | France |
Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors (ICMJE) guidelines. De-identified individual participant data will be available from the corresponding author on reasonable request after publication of the study results.
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|
| Standard pan-sinusal Radiotherapy | Radiation | The target volumes to be delineated are as follows:
|
|
| measured at 12 months after radiotherapy |
| Tumor response | Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors) | 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) | 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). | From the start of the study and up to 18 months after radiotherapy |
| 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 | During radiotherapy |
| Tissue changes | Tissue changes observed on imaging and their correlation with the toxicities observed | 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) | 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) | from the start of the study and up to 18 months after radiotherapy |
| CHU CAEN | Not yet recruiting | Caen | France |
|
| Centre Oscar Lambret | Not yet recruiting | Lille | France |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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