Cancer Clinical Trial
— ST-IGRT-ORLOfficial title:
Evaluation of the ExacTrac® Imaging Device for the Repositioning Quality of Patients Undergoing an External ENT Radiotherapy
Monocentric, category 2 study according to Jardé Law (minimal risks and constraints) of three prospective cohorts: Tumors located at the oropharynx, the oral cavity and the larynx-hypopharynx. The main objective is to evaluate the 3D vector of the absolute residual positioning error observed with the CBCT reference imaging, after repositioning performed with ExacTrac®. The secondary objectives are to evaluate: 1) the rate of residual errors ≥2mm (translations in all directions) and ≥2 ° (rotations in all directions) on CBCT imaging after repositionning with the ExacTrac® system; 2) the Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation; 3) the evolution of the relative position of the volume of the tumor at high risk of recurrence (CTVTHR) in relation to the spine over the entire duration of the treatment; 4) the impact of patient's weight loss, the advancement of RT and the realization of a chemotherapy / targeted therapy concomitant with RT, on the evolution of the relative position of the CTVTHR in relation to the column vertebral; 5) the dosimetric consequence of a strict bone registration on the CTVTHR coverage by calculating the post-treatment dose on the CBCT imaging.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | October 13, 2024 |
Est. primary completion date | April 13, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years old - Patient requiring an ENT radiotherapy with intensity modulation (IMR) in the oropharynx, oral cavity, hypopharynx or larynx with bilateral irradiation of the lymph node areas - Treatment planned on an accelerator equipped with a CBCT and the ExacTract® device - Patient affiliated to a social security system - Informed consent dated and signed Exclusion Criteria: - Pregnant or breastfeeding woman - Patient under totorship, curatorship or legal protection |
Country | Name | City | State |
---|---|---|---|
France | Centre Leon Berard | Lyon |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Verification of the feasibility of using the ExacTrac® system as a replacement for CBCT imaging for pre-treatment repositioning of ENT sphere cancers in adult patients receiving CRMI on a linear accelerator equipped with 2 modalities | 3D vector of the absolute residual positioning error observed with the CBCT reference imaging, after repositioning performed with ExacTrac® | Until the end of the radiotherapy treatment | |
Secondary | Evaluation of residual errors rates =2mm (translations in all directions) and =2 ° (rotations in all directions) on CBCT imaging after repositionning with the ExacTrac® system | Percentage of differences in translations and rotations >2mm and 2 ° between the 2 systems | Until the end of the radiotherapy treatment | |
Secondary | Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation | Average of translations and rotations obtained on the intrafraction images from ExacTrac® | Until the end of the radiotherapy treatment | |
Secondary | Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation | Standard deviation of translations and rotations obtained on the intrafraction images from ExacTrac® | Until the end of the radiotherapy treatment | |
Secondary | Evolution of the relative position of the volume of the tumor at high risk of recurrence (CTVTHR) in relation to the spine over the entire treatment duration | Differential 3D vector representative of the differences in translation between a bone and a soft tissue repositionning obtained during the pre-treatment repositioning correlated with the treatment progress | Until the end of the radiotherapy treatment | |
Secondary | Evaluation of the impact of patient's weight loss on the evolution of the relative position of the CTVTHR in relation to the spine | Correlation between the 3D vector of absolute residual error and the evolution of the Body Mass Index | Until the end of the radiotherapy treatment | |
Secondary | Evaluation of the impact of the RT progress on the evolution of the relative position of the CTVTHR in relation to the spine | Correlation between the 3D vector of absolute residual error and the treatment progress | Until the end of the radiotherapy treatment | |
Secondary | Evaluation fo the impact of a chemotherapy / targeted therapy performed concomitantly with RT, on the evolution of the relative position of the CTVTHR in relation to the spine | Correlation between the 3D vector of absolute residual error and the administration of chemotherapy / targeted therapyconcomitantly with RT | Until the end of the radiotherapy treatment | |
Secondary | Evaluation of the dosimetric consequence of a strict bone repositionning on the CTVTHR coverage by calculating the post-treatment dose on the CBCT imaging | Calculation of the dose effectively delivered to target volumes and organs at risk, recalculated from pre-treatment CBCT images | Until the end of the radiotherapy treatment |
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