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

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 Overview

• Status: Recruiting
• Conditions: Tumor, Solid
• Intervention / Treatment: Radiation: Radiotherapy in painting dose on histoscannographic mapping; Radiation: Standard pan-sinusal Radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Juliette THARIAT, Prof; Phone Number: 33231455050; Email: j.thariat@baclesse.unicancer.fr
• Study Contact Backup: Name: Vincent PATRON, MD; Phone Number: +33231063106; Email: patron-v@chu-caen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • Centre Francois Baclesse
    • Contact: JULIETTE THARIAT, PROF
  • Caen, France
    • Not yet recruiting
    • CHU Caen
    • Contact: VINCENT PATRON, MD
  • Lille, France
    • Not yet recruiting
    • Centre Oscar Lambret
    • Contact: XAVIER LIEM, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group: Radiotherapy in painting dose on histoscannographic mapping	Radiation: Radiotherapy 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).
Active Comparator: Control group: standard pan-sinus Radiotherapy	Radiation: Standard 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: IMRT; nasal; sinus; Mucosal toxicity
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms; Fistula; Therapeutics; Radiotherapy
• Other Study ID Numbers: 2022-A02011-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors (ICMJE) guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No