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NCT Number: NCT07305727

A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

0466684236

Frédéric FITENI, Professor

CONTACT

[email protected]

+334.34.03.46.69

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: EPICOL-R

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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