Tumor, Solid
Conditions
Keywords
IMRT, sinus, nasal, Mucosal toxicity
Brief 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
Interventions
RADIATIONRadiotherapy 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).
RADIATIONStandard 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).
Sponsors
Centre Francois Baclesse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities | Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT. | 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
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | measured at 6 months after radiotherapy | Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors) |
| Quality of life evaluation | from the start of the study and up to 18 months after radiotherapy | Quality of life measured using the standardized self-administered questionnaire Quality of Life Questionnaire-Core 30 items QLQ-C30 score (min:0; max 100) |
| Description of acute and late clinical toxicities | From the start of the study and up to 18 months after radiotherapy | 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). |
| Dosimetry to healthy organs | During radiotherapy | 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 |
| Tissue changes | from the start of the study and up to 18 months after radiotherapy | Tissue changes observed on imaging and their correlation with the toxicities observed |
Countries
France
Contacts
CONTACTVincent PATRON, MD
CONTACTJuliette THARIAT, Prof
Outcome results
None listed