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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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

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

Study details
    Tumor
    Solid

NCT05943119

Centre Francois Baclesse

20 March 2024

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