Vaginal CancerTRIDENTNCT06314568
Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer
An observational study of Vaginal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Cancer
- What is being tested?
- Radiochemotherapy plus interventional radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 278 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2024to 31 Dec 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Women with vaginal cancer that after first consultation will undergo to radiochemotherapy and interventional radiotherapy
Who may be able to join
- Age more than18 years old
- Performance status 0,1
- Hystological diagnosis of squamous vaginal cancer
- HPV, p16, p53 status
- Stage I, II, III and IV (AJCC 2018th version)
- Stadiation with magnetic resonance and positron emission tomography
- Informed consensus
Who cannot join
- Age inferior 18 years old
- Performance status more than 2
- Previous cancer in the last ten 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 pathologies 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
Roma, 00168
VALENTINA LANCELLOTTA, +390630155701, valentina.lancellotta@policlinicogemelli.it
VALENTINA LANCELLOTTA
About this study
Official title: Radiochemotherapy Treatment Followed by Interventional Radiotherapy in Patients Affected by Vagina Carcinoma Multi-centric Prospective Observational Study Trimodal Definitive Invasive Vaginal Carcinoma Treatment
Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer
Read the detailed description
Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy (45Gy on pelvis and tumor plus chemotherapy with cisplatinum) followed by interventional radiotherapy (28Gy on residual tumor) in patients affected by vaginal cancer
- Conditions
- Vaginal Cancer
- Being tested
- Radiochemotherapy plus interventional radiotherapy
- Medical subject headings
- Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiochemotherapy plus interventional radiotherapyRadiation
All patients with vaginal cancer will undergo radiochemotherapy (45 Gy on pelvis and tumor in association with cisplatinum) plus interventional radiotherapy (28 Gy on residual disease) with exclusive intent
| Study group | Role | What they receive |
|---|---|---|
| Patients with vaginal cancer | Patients affected by vaginal cancer Receives: Radiation: Radiochemotherapy plus interventional radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control
Local control, the Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
Measured: 6 months
Secondary outcomes (6)
Cancer specific overall survival
The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
Measured: 6 months
Toxicities
The safety and tolerability profile of the treatment will be defined by the frequency and severity of adverse reactions as well as their possible correlation with the treatment received.
Measured: 6 months
Overall survivall
The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
Measured: 6 months
Disease free survivall
The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
Measured: 6 months
Metastasis free survival
The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
Measured: 6 months
Changes in quality of life over time
Anova for repeated measures or the corresponding non-parametric Friedman test will be used to identify changes in quality of life over time.
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 posted18 Mar 2024
- Study start15 Mar 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal CancerStudies 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
- 278 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VALENTINA LANCELLOTTA, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314568
- Sponsor's protocol ID
- 6350
- Acronym
- TRIDENT
- Status last verified
- Aug 2025
- First submitted
- 11 Mar 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
- Radiochemotherapy Treatment Followed by Interventional Radiotherapy in Patients Affected by Vagina Carcinoma Multi-centric Prospective Observational Study Trimodal Definitive Invasive Vaginal Carcinoma Treatment
- ClinicalTrials.gov ID
- NCT06314568
- Acronym / sponsor ID
- TRIDENT / 6350
- Conditions
- Vaginal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Mar 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.
Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer
Detailed description
Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy (45Gy on pelvis and tumor plus chemotherapy with cisplatinum) followed by interventional radiotherapy (28Gy on residual tumor) in patients affected by vaginal cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with vaginal cancer | – | Radiation: Radiochemotherapy plus interventional radiotherapyPatients affected by vaginal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with vaginal cancer that after first consultation will undergo to radiochemotherapy and interventional radiotherapy
Key inclusion criteria (7 listed)
- Age more than18 years old
- Performance status 0,1
- Hystological diagnosis of squamous vaginal cancer
- HPV, p16, p53 status
- Stage I, II, III and IV (AJCC 2018th version)
Key exclusion criteria (8 listed)
- Age inferior 18 years old
- Performance status more than 2
- Previous cancer in the last ten 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 |
|---|---|---|
| Radiochemotherapy plus interventional radiotherapyAll patients with vaginal cancer will undergo radiochemotherapy (45 Gy on pelvis and tumor in association with cisplatinum) plus interventional radiotherapy (28 Gy on residual disease) with exclusive intent | Radiation | Patients with vaginal cancer |
Primary outcome
Local Control
Time frame: 6 months
Local control, the Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
6 secondary outcomes
Cancer specific overall survival
Time frame: 6 months
Toxicities
Time frame: 6 months
Overall survivall
Time frame: 6 months
Disease free survivall
Time frame: 6 months
Metastasis free survival
Time frame: 6 months
Changes in quality of life over time
Time frame: 6 months
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 Policlinico Universitario Agostino 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 Vaginal Cancer, 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 7 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, MD (+390630155701, valentina.lancellotta@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (time frame: 6 months). 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.