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NCT Number: NCT05943119

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

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

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Key information

Conditions

Tumor, Solid Fistula Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU CAEN, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy in painting dose on histoscannographic mapping

Radiation

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 Radiotherapy

Radiation

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Tumor response

    Time frame: measured at 6 months after radiotherapy

    Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)

  2. Tumor response

    Time frame: measured at 12 months after radiotherapy

    Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)

  3. Tumor response

    Time frame: measured at 18 months after radiotherapy

    Tumor response according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors)

  4. Quality of life evaluation

    Time frame: from the start of the study and up to 18 months after radiotherapy

    Quality of life measured using the standardized self-administered questionnaire Quality of Life Questionnaire-Core 30 items QLQ-C30 score (min:0; max 100)

  5. Description of acute and late clinical toxicities

    Time frame: From the start of the study and up to 18 months after radiotherapy

    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).

  6. Dosimetry to healthy organs

    Time frame: During radiotherapy

    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

  7. Tissue changes

    Time frame: from the start of the study and up to 18 months after radiotherapy

    Tissue changes observed on imaging and their correlation with the toxicities observed

  8. Quality of life evaluation

    Time frame: from the start of the study and up to 18 months after radiotherapy

    Quality of life measured using the standardized self-administered questionnaire Head and Neck QLQ-HN43 score (min:0; max 100)

  9. Quality of life evaluation

    Time frame: from the start of the study and up to 18 months after radiotherapy

    Quality of life measured using the standardized self-administered questionnaire : SNOT-22 (Sino-Nasal Outcome Test) (nasal symptoms score:min:0; max 5)

Other outcomes

  1. Assessment of molecular and cellular changes following radiation therapy in order to study potential toxicities affecting the mucous membranes and the surface of flaps, using an innovative, non-invasive surface analysis method.

    Time frame: Before, during, and 3 months after radiation therapy

    Change in the molecular profile with spidermass technology of nasal swabs and plasma

Study contacts

Contact information is provided by the study sponsor or research team.

Juliette THARIAT, Prof

CONTACT

[email protected]

33231455050

Vincent PATRON, MD

CONTACT

[email protected]

+33231063106

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: SinocaRT

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jul 13, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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