Clinical trial · Interventional
Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
NCT05943119CI-TRIAL-00116650SinocaRTrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor, Solid | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy in painting dose on histoscannographic mapping | Radiation | — | UNRESOLVED |
| Standard pan-sinusal Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group: Radiotherapy in painting dose on histoscannographic mapping
- interventionNames
- Radiation: Radiotherapy in painting dose on histoscannographic mapping
- type
- ACTIVE_COMPARATOR
- label
- Control group: standard pan-sinus Radiotherapy
- interventionNames
- Radiation: Standard pan-sinusal Radiotherapy
Primary outcomes (1)
- measure
- Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities
- timeFrame
- Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDThariat J, Clarisse B, Carsuzaa F, Lequesne J, Leconte A, Larnaudie A, Bouter J, Liem X, Humbert M, Patron V. Dose-painting after multi-block endoscopic endonasal surgery in sinonasal tumours: protocol for the SinocaRT randomised phase II trial. BMJ Open. 2026 Aug 24;16(8):e113543. doi: 10.1136/bmjopen-2025-113543. PMID 42637259