MR-Only Based Adaptive External Beam Radiation Therapy of Cervical Cancer on Ethos Therapy: Feasibility Study

Cervical Cancer Clinical Trial

— Ethos Col  

Official title:

MR-Only Based Adaptive External Beam Radiation Therapy of Cervical Cancer on Ethos

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909111
• Other study ID #: COL-ETHOS
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: February 1, 2026

Study information

• Verified date: June 2023
• Source: Institut Sainte Catherine
• Contact: Catherine Khamphan, PhD
• Phone: 0490276543
• Email: c.khamphan[@]isc84.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current management of patients treated with External Beam Radiation Therapy (EBRT) for cervical cancer with a classical Image-guided Radiation Therapy (IGRT) strategy involves a complex, not entirely satisfactory, treatment workflow. Indeed, in our institution, two workflows have been designed to take into account the inter-fraction motion of cervix and uterus : an Internal Target Volume (ITV)-based approach and a plan of the day strategy requiring both several planning-CT (Computed Tomography) acquisitions with variable bladder filling.The upcoming installation of a Varian Ethos therapy system in our institution will allow us to implement a less cumbersome online adaptive radiotherapy strategy (oART), which, by conforming to the daily anatomy, will enable a reduction in the Clinical Target Volume (CTV) to Planning Target Volume (PTV) margins leading to an expected reduction in dose delivered to organs at risk (OAR) .On the other hand, MR (Magnetic Resonance)-only treatment planning is playing an increasing role in radiotherapy, notably in the treatment of prostate cancer. MR-only workflows are known (a) to provide the most reliable delineation in soft tissues and (b) to decrease spatial uncertainties by suppressing the Magnetic Resonance Imaging (MRI)-CT co-registration. Regarding the management of cervical cancer, the importance of MRI is well established and its use becomes essential. Combining a MR-only workflow with an adaptative one on the Varian Ethos system, could lead to an improved management of patients treated for cervical cancer with an expected reduction in margins and volumes treated (thanks to MRI delineation and online adaptation) and therefore a reduction of OAR toxicity. Including regular multi-parametric MR imaging during and after the course of the treatment could also provide in the future an assessment of the treatment response. One of the important challenges in developing this specific workflow is to have a reliable synthetic CT (derived from MRI) to (a) provide electron or mass density for treatment planning calculations and (b) allow accurate online repositioning/deformation with Ethos Cone Beam Computed Tomography (CBCT). The other fundamental challenge is to provide a formal assessment of the clinical benefit of introducing MR-only simulation and planning in an oART workflow.

This project aims to demonstrate the feasibility of setting up an adaptive workflow on the ETHOS platform with the sole use of MR patient image.The project is divided into two parts. The first part consists in demonstrate the feasibility of the workflow on 15 patients with cervix cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years old

• Histologically proven cervical cancer (SCC, ADK ou adenous-SCC)

• Patient for curative RTCT treatment

• FIGO/TNM Stage IB2, IIA, IIB, IIIA, IIIB with or without lymph nodes involvement

• WHO < 2

• No pregnancy

• Informed consent dated and signed

• Patient affiliated or beneficiary of a social security scheme

• Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

• Metastatic disease

• Contraindications to IRM examinations (claustrophobia, presence of metallic elements..)

• Signes of active infection or serious health problems

• Historic of abdominal or pelvis RT

• Surgical history: partial or total hysterectomy

Related Conditions & MeSH terms

• Cervical Cancer
• MRI
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Magnetic resonance imaging
MRI weekly during the radiation treatment course (5 RMI added to the standard care)

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon

Sponsors (2)

Lead Sponsor	Collaborator
Recherche clinique	Varian Medical Systems

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor regression assessment CBCT	Volume Tumor regression on CBCT	18 months
Primary	Tumor regression assessment MRI	Volume Tumor regression on MRI	18 months