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

ConditionTumor, Solid
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Francois Baclesse

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Experimental group: Radiotherapy in painting dose on histoscannographic mappingExperimental treatment 1 intervention
Group B: Control group: standard pan-sinus RadiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.

Secondary outcomes

1

Tumor response

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

Time frame
measured at 6 months after radiotherapy
2

Tumor response

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

Time frame
measured at 12 months after radiotherapy
3

Tumor response

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

Time frame
measured at 18 months after radiotherapy
4

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)

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

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.

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.