A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer (EPICOL-R)

January 5, 2026 updated by: Centre Hospitalier Universitaire de Nīmes

Developing a Radiomic MRI Model Predictive of Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer. A Prognostic, Retrospective, Open-label, Multicenter, Descriptive and Analytical Clinical Cohort Study

Cervical cancer is the fourth most common cancer in women worldwide, with approximately 604,000 new cases in 2020.Treatment for locally advanced cervical cancer is based on a combination of radiotherapy and chemotherapy. The response to concomitant chemoradiotherapy vary from one woman to another. Predicting the response to these treatments would allow early consideration of alternative therapies for patients identified as less responsive to standard treatments. A 5-year recurrence-free survival is approximately 79% for stages IB and IIA and 59% for stages III and IVA, with approximately 36% of local failures despite chemoradiotherapy. In a few studies,the radiomic MRI approach in locally advanced cervical cancers has shown to be prognostic for locoregional recurrence or survival but these models still need to be explored and validated.The EPICOL cohort, a clinical-biological cohort of 136 patients treated with chemoradiotherapy for locally advanced cervical cancer at the Montpellier Cancer Institute or Nîmes University Hospital, will be used to develop a predictive model of response to chemoradiotherapy based on radiomic data from pelvic MRIs before and after treatment.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Cervical cancer is an invasive cancer that develops from the squamous epithelium of the cervix. Worldwide, cervical cancer is the fourth most common cancer in women, with approximately 604,000 new cases in 2020.Treatment for locally advanced cervical cancer (FIGO stage IB3 to IVA) is based on a combination of radiotherapy and chemotherapy (cisplatin 40 mg/m2 x5 or 6 or carboplatin area under the curve 2 if cisplatin is contraindicated). Responses to concomitant chemoradiotherapy remain highly heterogeneous from one woman to another, and predicting the response to these treatments would allow early consideration of alternative therapies for patients identified as less responsive to standard treatments. Indeed, 5-year recurrence-free survival is approximately 79% for stages IB and IIA and 59% for stages III and IVA, with approximately 36% of local failures despite chemoradiotherapy.

The radiomic MRI approach in locally advanced cervical cancers has shown in a few studies to be prognostic for locoregional recurrence or survival. However, these models still need to be explored and validated before they can be implemented in routine clinical practice.

The EPICOL cohort is a clinical-biological cohort of 136 patients treated with chemoradiotherapy for locally advanced cervical cancer at the Montpellier Cancer Institute or Nîmes University Hospital.

The aim is to develop a predictive model of response to chemoradiotherapy based on radiomic data from pelvic MRIs before and after treatment from the EPICOL cohort.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Gard
      • Nîmes, Gard, France, 30029
        • Recruiting
        • Nîmes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

For this study, data from 120 patients for whom we have MRI data from the EPICOL cohort (136 patients included) will be used.

Description

Inclusion Criteria:

  • Patients treated with exclusive radio-chemotherapy for locally advanced cervical cancer (stage Ib-IVb according to the FIGO classification).
  • Patients with a minimum of 2 years of post-treatment follow-up.
  • Patients for whom the initial biopsy specimen (prior to treatment) is available.
  • Patients who have not expressed their opposition to participating in the study.
  • Patients who are affiliated with or beneficiaries of a health insurance plan.

Exclusion Criteria:

  • Patients under judicial protection, guardianship, or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic role of a magnetic resonance imaging radiomic model on progression-free survival in patients treated for locally advanced cervical cancer.
Time Frame: Month 24
Time from diagnosis to death from any cause or progression (according to RECIST v1.1 criteria) at 24 months of follow-up.
Month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic role of an magnetic resonance imaging radiomic model on overall survival in patients treated for locally advanced cervical cancer.
Time Frame: Month 24
Time between treatment initiation and death from any cause at 24 months of follow-up.
Month 24
Correlation between the radiomic magnetic imaging radiomic model and Programmed cell Death protein 1 (PD-L1) expression.
Time Frame: Month 24
Collection of Programmed cell Death protein 1 (PD-L1) expression levels from biopsies from the EPICOL cohort.
Month 24
Correlation between the radiomic magnetic resonance imaging model and tumor-infiltrating lymphocytes (TILs).
Time Frame: Month 24
Collection of tumor-infiltrating lymphocyte (TIL) expression levels in biopsies from the EPICOL cohort.
Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Estimated)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIRIC/2024/FF01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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