Actively Recruiting
EROS 3 Study Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy Brachytherapy in Terms of Overall Toxicity and Sexual Activity
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-15
129
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of an accelerated high dose rate interventional radiotherapy (IRT-HDR) on patients with locally advanced cervical cancer, specifically stages IB2 to IVA. This observational, prospective study aims to assess both the short-term and long-term intestinal, urinary, and vaginal side effects, as well as how the treatment impacts sexual activity. The study is focused on patients receiving combined radiochemotherapy followed by this accelerated brachytherapy approach. Participants will undergo four fractions of interventional radiotherapy within one week as part of their treatment after initial radiochemotherapy. This accelerated schedule is designed to deliver high doses of radiation directly to the uterus. The study is monocentric and monitors patients closely to evaluate the overall toxicity and changes in sexual activity during and after treatment. Throughout the study, participants will be regularly assessed for gastrointestinal and urinary toxicities, both acute and late, over a period of six months. Sexual activity will also be evaluated during this timeframe. These evaluations include clinical examinations and patient-reported outcomes, allowing researchers to understand the treatment's impact on quality of life. The total participation duration and detailed follow-up are structured to capture both immediate and longer-term effects of the therapy.
CONDITIONS
Brief Title
Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- ECOG performance status 0 to 2
- Histological diagnosis of squamous carcinoma and/or adenocarcinoma of the uterine cervix
- Cervical cancer stage IB2 to IVA according to FIGO 2018 staging
- No contraindications for pelvic MRI
- Signed informed consent to participate
You will not qualify if you...
- Age less than 18 years
- Performance status greater than 2
- Previous cancer diagnosis within the last 10 years
- Previous radiation treatment in the pelvic area
- Conditions contraindicating radiotherapy (e.g., genetic syndromes causing high radiosensitivity, active ulcerative colitis, acute diverticulitis, severe diverticulosis, chronic pelvic inflammation)
- Internal diseases contraindicating chemotherapy or radiochemotherapy (e.g., severe liver disease, heart disease, renal failure)
- Distant metastases outside pelvic lymph nodes
- Any significant medical condition interfering with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo four fractions of intrauterine interventional radiotherapy (brachytherapy) over one week following radiochemotherapy.
4 treatment visits (in-person)
Duration - 6 months
Participants are monitored for acute and late gastrointestinal and urinary toxicities as well as sexual activity.
Regular follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
V
VALENTINA LANCELLOTTA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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