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.
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
- Conditions the study is for
- Cervical Cancer, Online Adaptative Radiation Therapy, MRI
- 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
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- 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.
France1 site, 1 recruiting
- Recruiting
Institut Sainte Catherine
Avignon
Antoine Arnaud, DM, a.arnaud@isc84.org
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.
- Conditions
- Cervical Cancer, Online Adaptative Radiation Therapy, MRI
- 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 group | Role | What they receive |
|---|---|---|
| MRI assessment during radiation therapy course | Experimental | Patients 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.
Tumor regression assessment CBCT
Volume Tumor regression on CBCT
Measured: 18 months
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.
- First posted18 Jun 2023
- Study start1 Dec 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Recherche clinique
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor-investigator, Recherche clinique, Institut Sainte Catherine
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-Only Based Adaptive External Beam Radiation Therapy of Cervical Cancer on Ethos
- ClinicalTrials.gov ID
- NCT05909111
- Acronym / sponsor ID
- Ethos Col / COL-ETHOS
- Conditions
- Cervical Cancer, Online Adaptative Radiation Therapy, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Recherche cliniqueUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI assessment during radiation therapy course | Experimental | Diagnostic Test: Magnetic resonance imagingPatients perform on MRI every week during the 5-weeks treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingMRI weekly during the radiation treatment course (5 RMI added to the standard care) | Diagnostic test | MRI assessment during radiation therapy course |
Primary outcome
Tumor regression assessment CBCT
Time frame: 18 months
Volume Tumor regression on CBCT
Tumor regression assessment MRI
Time frame: 18 months
Volume Tumor regression on MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.