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

Phase 2RecruitingNCT05943119

Centre Francois Baclesse52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tumor, Solid

Interventions

Radiotherapy in painting dose on histoscannographic mappingRADIATION

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).

Standard pan-sinusal RadiotherapyRADIATION

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Centre Francois Baclesse

Caen, France

RECRUITING

CHU CAEN

Caen, France

NOT_YET_RECRUITING

Centre Oscar Lambret

Lille, France

NOT_YET_RECRUITING

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.

Time frame: Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.

Central Contacts

Vincent PATRON, MD

CONTACT

+33231063106 patron-v@chu-caen.fr

Juliette THARIAT, Prof

CONTACT

33231455050 j.thariat@baclesse.unicancer.fr

Data from ClinicalTrials.gov

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