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

C

Centre Francois Baclesse

Status and phase

Enrolling
Phase 2

Conditions

Tumor, Solid

Treatments

Radiation: Radiotherapy in painting dose on histoscannographic mapping
Radiation: Standard pan-sinusal Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05943119
2022-A02011-42

Details and patient eligibility

About

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

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Experimental group: Radiotherapy in painting dose on histoscannographic mapping
Experimental group
Treatment:
Radiation: Radiotherapy in painting dose on histoscannographic mapping
Control group: standard pan-sinus Radiotherapy
Active Comparator group
Treatment:
Radiation: Standard pan-sinusal Radiotherapy

Trial contacts and locations

3

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Central trial contact

Juliette THARIAT, Prof; Vincent PATRON, MD

Data sourced from clinicaltrials.gov

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