Evaluating radiochemotherapy and interventional radiotherapy for vaginal cancer
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
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06314568 · Data updated 2026-11-12
This study is testing a new treatment plan that combines radiation and chemotherapy for people with vaginal cancer to see if it helps them live longer and control the disease better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 278 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | March 15, 2024 |
| Main results expected | March 31, 2026 |
| Study ends | December 31, 2028 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT06314568 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with a histological diagnosis of squamous vaginal cancer at stages I to IV.
✕Probably not a fit
Patients with performance status greater than 2 or those with distant metastases outside pelvic lymph nodes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational multicenter study aims to assess the effectiveness of radiochemotherapy followed by interventional radiotherapy in patients diagnosed with vaginal cancer. The treatment regimen includes administering 45Gy of radiation to the pelvis and tumor, combined with chemotherapy using cisplatin, followed by an additional 28Gy of interventional radiotherapy targeting any residual tumor. The study will evaluate local control and cancer-specific survival outcomes in affected patients.
Why it matters
Potential benefit: If successful, this approach could improve local control and survival rates for patients with vaginal cancer.
How similar studies have gone: Other studies have shown promising results with similar radiotherapy approaches in treating various cancers, suggesting potential for success in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Valentina Lancellotta — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Valentina Lancellotta, Md
- Email: valentina.lancellotta@policlinicogemelli.it
- Phone: +390630155701
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.