Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery

Centre Francois Baclesse3 sites in 1 country52 target enrollmentMarch 11, 2024

ConditionsTumor, Solid

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Tumor, Solid
Sponsor: Centre Francois Baclesse
Enrollment: 52
Locations: 3
Primary Endpoint: Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 11, 2024

End Date

March 1, 2029

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Francois Baclesse

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities

Time Frame: 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.