Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05909111

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

Led by Recherche clinique · Updated on 2025-01-22

15

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

R

Recherche clinique

Lead Sponsor

V

Varian Medical Systems

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years old
  • Histologically confirmed cervical cancer (SCC, ADK or adenosquamous carcinoma)
  • Planned for curative radiation therapy with chemotherapy
  • FIGO/TNM Stage IB2, IIA, IIB, IIIA, IIIB with or without lymph node involvement
  • WHO performance status less than 2
  • Not pregnant
  • Signed and dated informed consent
  • Affiliated with or beneficiary of a social security scheme
  • Free, informed, and written consent signed by participant and investigator before any study-related examination
Not Eligible

You will not qualify if you...

  • Presence of metastatic disease
  • Contraindications to MRI (such as claustrophobia or metallic implants)
  • Signs of active infection or serious health problems
  • History of abdominal or pelvic radiation therapy
  • History of partial or total hysterectomy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institut Sainte Catherine

Avignon, France

Actively Recruiting

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Research Team

C

Catherine Khamphan, PhD

CONTACT

A

Aurélien Badey

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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