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Trial Title:
Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
NCT ID:
NCT05943119
Condition:
Tumor, Solid
Conditions: Official terms:
Carcinoma
Conditions: Keywords:
IMRT
sinus
nasal
Mucosal toxicity
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy in painting dose on histoscannographic mapping
Description:
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).
Arm group label:
Experimental group: Radiotherapy in painting dose on histoscannographic mapping
Intervention type:
Radiation
Intervention name:
Standard pan-sinusal Radiotherapy
Description:
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).
Arm group label:
Control group: standard pan-sinus Radiotherapy
Summary:
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Francois Baclesse
Address:
City:
Caen
Country:
France
Status:
Recruiting
Contact:
Last name:
JULIETTE THARIAT, PROF
Facility:
Name:
CHU CAEN
Address:
City:
Caen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
VINCENT PATRON, MD
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
XAVIER LIEM, MD
Start date:
March 11, 2024
Completion date:
March 2029
Lead sponsor:
Agency:
Centre Francois Baclesse
Agency class:
Other
Source:
Centre Francois Baclesse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05943119
