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Phase II Study of Exclusive Intensity Modulated Radiation Therapy (IMRT) in Dose Painting for Sinus Carcinomas After Endoscopic Surgery (SinocaRT)

Primary Purpose

Tumor, Solid

Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
RCMI in painting dose on histoscannographic mapping
Standard pan-sinusal IMRT
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumor, Solid focused on measuring IMRT, sinus, nasal, Mucosal toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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

Sites / Locations

  • Centre Francois Baclesse
  • CHU CAEN
  • Centre Oscar Lambret

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group: IMRT in painting dose on histoscannographic mapping

Control group: standard pan-sinus IMRT

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 5, 2023
Last Updated
July 5, 2023
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT05943119
Brief Title
Phase II Study of Exclusive Intensity Modulated Radiation Therapy (IMRT) in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
Acronym
SinocaRT
Official Title
Phase II Study of Exclusive Intensity Modulated Radiation Therapy (IMRT) in Dose Painting for Sinus Carcinomas After Endoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
March 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The patient is randomized to one of the following groups: Experimental group: IMRT in painting dose on histoscannographic mapping Control group: standard pan-sinus IMRT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Solid
Keywords
IMRT, sinus, nasal, Mucosal toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group: IMRT in painting dose on histoscannographic mapping
Arm Type
Experimental
Arm Title
Control group: standard pan-sinus IMRT
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
RCMI in painting dose on histoscannographic mapping
Intervention 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).
Intervention Type
Radiation
Intervention Name(s)
Standard pan-sinusal IMRT
Intervention 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).
Primary Outcome Measure Information:
Title
Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EMMANUEL KAMMERER, MD
Phone
33299253000
Email
e.kammerer@rennes.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Juliette THARIAT, Prof
Phone
33231455050
Email
j.thariat@baclesse.unicancer.fr
Facility Information:
Facility Name
Centre Francois Baclesse
City
Caen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JULIETTE THARIAT, PROF
Facility Name
CHU CAEN
City
Caen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VINCENT PATRON, MD
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XAVIER LIEM, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Phase II Study of Exclusive Intensity Modulated Radiation Therapy (IMRT) in Dose Painting for Sinus Carcinomas After Endoscopic Surgery

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