Radiotherapy for sinus carcinomas after surgery

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

This study tests whether a new type of targeted radiotherapy can help people with sinus cancer feel better after surgery compared to standard treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Francois Baclesse (other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Caen and 2 other locations)
• Trial ID: NCT05943119 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of intensity-modulated radiotherapy (IMRT) using a dose-painting technique based on histoscannographic mapping for patients with nasosinus carcinoma who have undergone endoscopic surgery. Participants are randomized into two groups: one receiving the experimental IMRT treatment and the other receiving standard pan-sinus radiotherapy. The goal is to determine if the tailored approach can improve outcomes while minimizing mucosal toxicity compared to conventional methods.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with histologically confirmed nasosinus carcinoma who have recently undergone endoscopic sinonasal surgery.

Not a fit: Patients with distant metastases or those who have not undergone surgery for their tumor will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better treatment outcomes and reduced side effects for patients with sinus carcinomas.

How similar studies have performed: Other studies using intensity-modulated radiotherapy have shown promising results, suggesting potential success for this novel application.

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

Where this trial is running

Caen and 2 other locations

• Centre Francois Baclesse — Caen, France (RECRUITING)
• CHU CAEN — Caen, France (NOT_YET_RECRUITING)
• Centre Oscar Lambret — Lille, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Vincent PATRON, MD

Conditions: Tumor, Solid, IMRT, sinus, nasal, Mucosal toxicity