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

Primary Purpose

Cervical Cancer, Online Adaptative Radiation Therapy, MRI

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic resonance imaging
Sponsored by
Recherche clinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

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

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

Sites / Locations

  • Institut Sainte CatherineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI assessment during radiation therapy course

Arm Description

Patients perform on MRI every week during the 5-weeks treatment

Outcomes

Primary Outcome Measures

Tumor regression assessment CBCT
Volume Tumor regression on CBCT
Tumor regression assessment MRI
Volume Tumor regression on MRI

Secondary Outcome Measures

Full Information

First Posted
August 8, 2022
Last Updated
June 8, 2023
Sponsor
Recherche clinique
Collaborators
Varian Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT05909111
Brief Title
MR-Only Based Adaptive External Beam Radiation Therapy of Cervical Cancer on Ethos Therapy: Feasibility Study
Acronym
Ethos Col
Official Title
MR-Only Based Adaptive External Beam Radiation Therapy of Cervical Cancer on Ethos
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Recherche clinique
Collaborators
Varian Medical Systems

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Online Adaptative Radiation Therapy, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI assessment during radiation therapy course
Arm Type
Experimental
Arm Description
Patients perform on MRI every week during the 5-weeks treatment
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic resonance imaging
Intervention Description
MRI weekly during the radiation treatment course (5 RMI added to the standard care)
Primary Outcome Measure Information:
Title
Tumor regression assessment CBCT
Description
Volume Tumor regression on CBCT
Time Frame
18 months
Title
Tumor regression assessment MRI
Description
Volume Tumor regression on MRI
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Khamphan, PhD
Phone
0490276543
Email
c.khamphan@isc84.org
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélien Badey
Phone
0490276563
Email
a.badey@isc84.org
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Arnaud, DM
Email
a.arnaud@isc84.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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