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

Launched by CENTRE FRANCOIS BACLESSE · Jul 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a type of radiation therapy called intensity-modulated radiotherapy (IMRT) to treat sinus cancers after patients have had surgery to remove the tumor. The researchers want to see if a special technique called "dose painting," which targets the radiation to specific areas based on maps of the tumor, is more effective than the standard radiation treatment that covers a larger area. Participants will be randomly assigned to either receive the experimental dose painting method or the standard treatment.

To be eligible for this trial, patients must be over 18 years old and have been diagnosed with a specific type of sinus cancer confirmed by a doctor. They should have had surgery for their cancer within the last two months and need radiation treatment afterward. Patients who have certain other health conditions, such as distant spread of cancer or recent treatment with chemotherapy, cannot participate. If you join the trial, you will be monitored closely and receive care from the medical team to ensure your safety throughout the study. Your participation could help improve treatment options for future patients with similar conditions.

Gender

ALL

Eligibility criteria

• 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