Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06398938

Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy

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+/-).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Rome, 00168, Italy

Location status: Recruiting

Location contact

Valentina Lancellotta

CONTACT

[email protected]

+0630159248

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Interventional Radiotherapy

Radiation

The patients will undergo four IRT fractions in one week

Primary outcomes

  1. 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

  2. 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

  3. Sexual activity

    Time frame: 6 months

    Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy

Study contacts

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

VALENTINA LANCELLOTTA

CONTACT

[email protected]

3441177911

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: EROS3

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 3, 2024
Registry last updated
Aug 15, 2025

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.

Published trials that share one or more normalized conditions with this study.