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

Phase 2

Recruiting

• Conditions: Tumor, Solid
• Interventions: Radiation: Standard pan-sinusal Radiotherapy; Radiation: Radiotherapy in painting dose on histoscannographic mapping

• Registration Number: NCT05943119
• Lead Sponsor: Centre Francois Baclesse

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-13
• Status Verified: 2024-03
• Study Start: 2024-03-11
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2028-01
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients >18 years of age
• Patient with histologically confirmed nasosinus carcinoma
• 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
• Delay between surgery and radiotherapy greater than 8 weeks
• Other histologies (melanoma, sarcoma, lymphoma, etc.)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group: standard pan-sinus Radiotherapy	Standard pan-sinusal Radiotherapy	-
Experimental group: Radiotherapy in painting dose on histoscannographic mapping	Radiotherapy in painting dose on histoscannographic mapping	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Centre Francois Baclesse; 🇫🇷 Caen, France

CHU CAEN; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France