NCT05943119

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
35mo left

Started Mar 2024

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Mar 2024Mar 2029

First Submitted

Initial submission to the registry

July 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

3.8 years

First QC Date

July 5, 2023

Last Update Submit

July 23, 2025

Conditions

Tumor, Solid

Keywords

IMRTsinusnasalMucosal toxicity

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Experimental group: Radiotherapy in painting dose on histoscannographic mapping

EXPERIMENTAL
Radiation: Radiotherapy in painting dose on histoscannographic mapping

Control group: standard pan-sinus Radiotherapy

ACTIVE COMPARATOR
Radiation: Standard pan-sinusal Radiotherapy

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).

Experimental group: Radiotherapy in painting dose on histoscannographic mapping
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).

Control group: standard pan-sinus Radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Francois Baclesse

Caen, France

RECRUITING

CHU CAEN

Caen, France

NOT YET RECRUITING

Centre Oscar Lambret

Lille, France

NOT YET RECRUITING

MeSH Terms

Conditions

NeoplasmsFistula

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Vincent PATRON, MD

CONTACT

+33231063106patron-v@chu-caen.fr

Juliette THARIAT, Prof

CONTACT

33231455050j.thariat@baclesse.unicancer.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 13, 2023

Study Start

March 11, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations

FR(3)