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

NCT ID: NCT05943119

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2029-03-31

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

Conditions

Tumor, Solid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group: Radiotherapy in painting dose on histoscannographic mapping

Group Type: EXPERIMENTAL

Radiotherapy in painting dose on histoscannographic mapping

Intervention Type: RADIATION

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).

Control group: standard pan-sinus Radiotherapy

Group Type: ACTIVE_COMPARATOR

Standard pan-sinusal Radiotherapy

Intervention Type: RADIATION

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Francois Baclesse

Caen, , France

Site Status: RECRUITING

CHU CAEN

Caen, , France

Site Status: NOT_YET_RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Vincent PATRON, MD

Role: CONTACT

patron-v@chu-caen.fr

+33231063106

Juliette THARIAT, Prof

Role: CONTACT

j.thariat@baclesse.unicancer.fr

33231455050

Facility Contacts

JULIETTE THARIAT, PROF

Role: primary

VINCENT PATRON, MD

Role: primary

XAVIER LIEM, MD

Role: primary

Other Identifiers

2022-A02011-42

Identifier Type: -

Identifier Source: org_study_id