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Recruiting NCT05943119

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

Phase II Interventional Tumor, Solid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy in painting dose on histoscannographic mapping, Standard pan-sinusal Radiotherapy.
Who it may be relevant to
Registry conditions: Tumor, Solid. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Interventions

  • Radiation Radiotherapy in painting dose on histoscannographic mapping
    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-r
  • Radiation Standard pan-sinusal Radiotherapy
    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 outcome measures

  • 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.]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 3 centers
  • Centre Francois Baclesse — Caen
  • CHU CAEN — Caen
  • Centre Oscar Lambret — Lille

Identifiers

NCT: NCT05943119 · 2022-A02011-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗