AzTrials
AzTrials

Cervical CancerEthos ColNCT05909111

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

A study testing Magnetic resonance imaging in people with Cervical Cancer and Online Adaptative Radiation Therapy, run by Recherche clinique at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Magnetic resonance imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteFrance
Study dates
1 Dec 2022to 1 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Catherine Khamphan, PhD contact

0490276543

c.khamphan@isc84.org

Aurélien Badey contact

0490276563

a.badey@isc84.org

France1 site, 1 recruiting
  • Institut Sainte Catherine

    Avignon

    Antoine Arnaud, DM, a.arnaud@isc84.org

    Recruiting

Other trials in France

About this study

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

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.

Being tested
Magnetic resonance imaging
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic resonance imagingDiagnostic test

    MRI weekly during the radiation treatment course (5 RMI added to the standard care)

Study groups in NCT05909111
Study groupRoleWhat they receive
MRI assessment during radiation therapy courseExperimentalPatients perform on MRI every week during the 5-weeks treatment
Receives: Diagnostic Test: Magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor regression assessment CBCT

    Volume Tumor regression on CBCT

    Measured: 18 months

  2. Tumor regression assessment MRI

    Volume Tumor regression on MRI

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start1 Dec 2022
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05909111
Sponsor's protocol ID
COL-ETHOS
Acronym
Ethos Col
Status last verified
Jan 2025
First submitted
8 Aug 2022
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic resonance imaging in people with Cervical Cancer and Online Adaptative Radiation Therapy, run by Recherche clinique at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catherine Khamphan, PhD (0490276543, c.khamphan@isc84.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor regression assessment CBCT (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in