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Recruiting NCT06398938

Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy

— Observational Locally Advanced Cervical Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interventional Radiotherapy.
Who it may be relevant to
Registry conditions: Locally Advanced Cervical Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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+/-).

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.

Interventions

  • Radiation Interventional Radiotherapy
    The patients will undergo four IRT fractions in one week

Primary outcome measures

  • Acute and late gastrointestinal toxicity [Time frame: 6 months]
  • Acute and late urinary toxicity [Time frame: 6 months]
  • Sexual activity [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli, IRCCS — Rome

Identifiers

NCT: NCT06398938 · 6676

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗