Tumor, SolidPhase 2SinocaRTNCT05943119
Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
A Phase 2 study testing Radiotherapy in painting dose on histoscannographic mapping and Standard pan-sinusal Radiotherapy in people with Tumor, Solid, run by Centre Francois Baclesse at 3 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- Radiotherapy in painting dose on histoscannographic mapping and Standard pan-sinusal Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Mar 2024to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Centre Francois Baclesse
Caen
JULIETTE THARIAT, PROF
- Not yet recruiting
CHU CAEN
Caen
VINCENT PATRON, MD
- Not yet recruiting
Centre Oscar Lambret
Lille
XAVIER LIEM, MD
About this study
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
- Being tested
- Radiotherapy in painting dose on histoscannographic mapping, Standard pan-sinusal Radiotherapy
- Keywords
- IMRT, sinus, nasal, Mucosal toxicity
- Medical subject headings
- Neoplasms, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy in painting dose on histoscannographic mappingRadiation
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).
Standard pan-sinusal RadiotherapyRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Radiotherapy in painting dose on histoscannographic mapping | Experimental | Not described Receives: Radiation: Radiotherapy in painting dose on histoscannographic mapping |
| Control group: standard pan-sinus Radiotherapy | Active comparator | Not described Receives: Radiation: Standard pan-sinusal Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities
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.
Measured: Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.
Secondary outcomes (9)
Tumor response
Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
Measured: measured at 6 months after radiotherapy
Tumor response
Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
Measured: measured at 12 months after radiotherapy
Tumor response
Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)
Measured: measured at 18 months after radiotherapy
Quality of life evaluation
Quality of life measured using the standardized self-administered questionnaire Quality of Life Questionnaire-Core 30 items QLQ-C30 score (min:0; max 100)
Measured: from the start of the study and up to 18 months after radiotherapy
Description of acute and late clinical toxicities
Description of acute and late clinical toxicities according to CTCAE terminology, as well as specific medical questionnaires and self-report questionnaires from the NCI-PRO-CTCAE (covering visual, auditory, and cognitive symptoms, as well as fatigue).
Measured: From the start of the study and up to 18 months after radiotherapy
Dosimetry to healthy organs
Standard dosimetric criteria specific to each healthy organ (pituitary gland, optic nerves, eyes, lenses, middle and inner ears, nasal mucosa, etc.): maximum dose in 2% of the volume, average dose, etc., using NTCP (normal tissue complication probability) models on dose-volume histograms and 3D dose maps
Measured: During radiotherapy
Tissue changes
Tissue changes observed on imaging and their correlation with the toxicities observed
Measured: from the start of the study and up to 18 months after radiotherapy
Quality of life evaluation
Quality of life measured using the standardized self-administered questionnaire Head and Neck QLQ-HN43 score (min:0; max 100)
Measured: from the start of the study and up to 18 months after radiotherapy
Quality of life evaluation
Quality of life measured using the standardized self-administered questionnaire : SNOT-22 (Sino-Nasal Outcome Test) (nasal symptoms score:min:0; max 5)
Measured: from the start of the study and up to 18 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start11 Mar 2024
- Primary completionJan 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943119
- Sponsor's protocol ID
- 2022-A02011-42
- Acronym
- SinocaRT
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors (ICMJE) guidelines. De-identified individual participant data will be available from the corresponding author on reasonable request after publication of the study results.
Publications
Thariat 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.
PubMed 42637259
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
- ClinicalTrials.gov ID
- NCT05943119
- Acronym / sponsor ID
- SinocaRT / 2022-A02011-42
- Conditions
- Tumor, Solid
- Keywords
- IMRT, sinus, nasal, Mucosal toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Radiotherapy in painting dose on histoscannographic mapping | Experimental | Radiation: Radiotherapy in painting dose on histoscannographic mapping |
| Control group: standard pan-sinus Radiotherapy | Active comparator | Radiation: Standard pan-sinusal Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy in painting dose on histoscannographic mappingThe 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). | Radiation | Experimental group: Radiotherapy in painting dose on histoscannographic mapping |
| Standard pan-sinusal RadiotherapyThe 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). | Radiation | Control group: standard pan-sinus Radiotherapy |
Primary outcome
Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities
Time frame: Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.
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.
9 secondary outcomes
Tumor response
Time frame: measured at 6 months after radiotherapy
Tumor response
Time frame: measured at 12 months after radiotherapy
Tumor response
Time frame: measured at 18 months after radiotherapy
Quality of life evaluation
Time frame: from the start of the study and up to 18 months after radiotherapy
Description of acute and late clinical toxicities
Time frame: From the start of the study and up to 18 months after radiotherapy
Dosimetry to healthy organs
Time frame: During radiotherapy
Tissue changes
Time frame: from the start of the study and up to 18 months after radiotherapy
Quality of life evaluation
Time frame: from the start of the study and up to 18 months after radiotherapy
Quality of life evaluation
Time frame: from the start of the study and up to 18 months after radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 42637259Thariat 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.
- Individual participant dataSharing planned: Yes. Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors (ICMJE) guidelines. De-identified individual participant data will be available from the corresponding author on reasonable request after publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy in painting dose on histoscannographic mapping and Standard pan-sinusal Radiotherapy in people with Tumor, Solid, run by Centre Francois Baclesse at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent PATRON, MD (+33231063106, patron-v@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities (time frame: Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.