Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy (EROS3)

August 12, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

EROS 3 Study Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy Brachytherapy in Terms of Overall Toxicity and Sexual Activity

To evaluate the degree of acute and long-term intestinal, urinary and vaginal toxicity, and the impact on sexual activity of an accelerated fractionation of high dose rate interventional radiotherapy (IRT-HDR) in patients with locally advanced cervical cancer (IB2 - VA, N+/-).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Observational, monocentric and prospective study. All patients with locally advanced cervix cancer will be underwent to radiochemotherapy followed by accelerated interventional radiotherapy (brachytherapy). Fist endpoints wer severe acute and late gastrointestinal, and urinary toxicities and sexual activity.

Study Type

Observational

Enrollment (Estimated)

129

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 Locations

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced cervix cancer

Description

Inclusion Criteria:

  • Age ≥18 years
  • ECOG 0-2
  • Histological diagnosis of squamous carcinoma and/or adenocarcinoma of the uterine cervix
  • FIGO IB2 Stadium - IVA (staging 20018)
  • No contraindications to performing MRI of the pelvis
  • Informed consent

Exclusion Criteria:

  • Age <18 years
  • PS >2
  • Previous cancer in the last 10 years
  • Previous radiation treatment in the region of interest
  • Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation)
  • Presence of internal diseases that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.)
  • Presence of distant metastases in sites other than the pelvic lymph nodes
  • Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study

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
Acute and late gastrointestinal toxicity
Time Frame: 6 months
Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
6 months
Acute and late urinary toxicity
Time Frame: 6 months
Acute and late urinary toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
6 months
Sexual activity
Time Frame: 6 months
Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
6 months

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: VALENTINA LANCELLOTTA, Fondazione Universiataria Policlinico A Gemelli IRCCS

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 (Actual)

May 6, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6676

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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