NCT05943119 Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
| NCT ID | NCT05943119 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Francois Baclesse |
| Condition | Tumor, Solid |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-03-11 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 52 participants in total. It began in 2024-03-11 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05943119 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tumor, Solid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05943119 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05943119 currently recruiting?
Yes, NCT05943119 is actively recruiting participants. Contact the research team at patron-v@chu-caen.fr for enrollment information.
Where is the NCT05943119 trial being conducted?
This trial is being conducted at Caen, France, Caen, France, Lille, France.
Who is sponsoring the NCT05943119 clinical trial?
NCT05943119 is sponsored by Centre Francois Baclesse. The trial plans to enroll 52 participants.