Locally Advanced Cervical CarcinomaEROS3NCT06398938
Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy
An observational study of Locally Advanced Cervical Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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+/-). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced Cervical Carcinoma
- What is being tested?
- Interventional Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 129 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with locally advanced cervix cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Rome, 00168
Valentina Lancellotta, +0630159248, valentina.lancellotta@policlinicogemelli.it
About this study
Official title: 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+/-).
Read the 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.
- Conditions
- Locally Advanced Cervical Carcinoma
- Being tested
- Interventional Radiotherapy
- Keywords
- cervical carcinoma, interventional radiotherapy, acute and late toxicities, radiochemotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional RadiotherapyRadiation
The patients will undergo four IRT fractions in one week
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and late gastrointestinal toxicity
Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
Measured: 6 months
Acute and late urinary toxicity
Acute and late urinary toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
Measured: 6 months
Sexual activity
Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start6 May 2024
- Primary completion30 May 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VALENTINA LANCELLOTTA, Principal investigator, Fondazione Universiataria Policlinico A Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398938
- Sponsor's protocol ID
- 6676
- Acronym
- EROS3
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EROS 3 Study Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy Brachytherapy in Terms of Overall Toxicity and Sexual Activity
- ClinicalTrials.gov ID
- NCT06398938
- Acronym / sponsor ID
- EROS3 / 6676
- Conditions
- Locally Advanced Cervical Carcinoma
- Keywords
- cervical carcinoma, interventional radiotherapy, acute and late toxicities, radiochemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced cervix cancer
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional RadiotherapyThe patients will undergo four IRT fractions in one week | Radiation | – |
Primary outcome
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
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
Sexual activity
Time frame: 6 months
Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
VALENTINA LANCELLOTTA principal investigator
Fondazione Universiataria Policlinico A Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Cervical Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VALENTINA LANCELLOTTA (3441177911, valentina.lancellotta@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute and late gastrointestinal toxicity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.