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

Tumor, Solid Clinical Trial

— SinocaRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943119
• Other study ID #: 2022-A02011-42
• Status: Recruiting
• Phase: Phase 2
• Start date: March 11, 2024
• Est. completion date: March 2029

Study information

• Verified date: March 2024
• Source: Centre Francois Baclesse
• Contact: EMMANUEL KAMMERER, MD
• Phone: 33299253000
• Email: e.kammerer[@]rennes.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: March 2029
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma
• Tumor, Solid

Intervention

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-risk areas (muscle, bone).
• 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).

Locations

Country	Name	City	State
France	Centre Francois Baclesse	Caen
France	CHU CAEN	Caen
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Toxicity grade = 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.