Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 11, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment approach for women with vaginal cancer. The researchers want to see how well a combination of chemotherapy, which uses medication to kill cancer cells, and radiotherapy, which uses high-energy radiation to target cancer, works in controlling the cancer and improving survival rates. The study is currently looking for participants who are female, over 18 years old, and have been diagnosed with squamous vaginal cancer in stages I through IV. They will also need to meet certain health criteria to ensure they can safely participate.
If you join the trial, you can expect to receive the treatment and have regular check-ups to monitor your progress. The study aims to gather information from multiple centers, meaning that many hospitals will take part, which could help improve future treatments for vaginal cancer. It’s important to know that if you have had other cancers recently, prior radiation therapy in the relevant area, or certain health issues, you may not be eligible to participate. This trial is a step toward finding better ways to treat vaginal cancer, and your involvement could contribute to important findings in this area.
Gender
FEMALE
Eligibility 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
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
VALENTINA LANCELLOTTA
Principal Investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported