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: EMMANUEL KAMMERER, MD; Phone Number: 33299253000; Email: e.kammerer@rennes.unicancer.fr
• Study Contact Backup: Name: Juliette THARIAT, Prof; Phone Number: 33231455050; Email: j.thariat@baclesse.unicancer.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 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 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.

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): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: IMRT; nasal; sinus; Mucosal toxicity
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 2022-A02011-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No