Actively Recruiting
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Led by CNAO National Center of Oncological Hadrontherapy · Updated on 2025-08-06
55
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).
CONDITIONS
Official Title
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Karnofsky Index of 70 or higher
- Histological or radiological diagnosis of pelvic and groin recurrence
- Contraindications for radical surgery
- No other distant disease progression or stable disease of known metastases for at least 6 months
- Previous radiation therapy on pelvis
- Tumor located at least 10 mm from the small intestine as shown by imaging
- Ability to have surgery to space intestinal loops if tumor is closer than 10 mm
- Use of biocompatible or anatomical non-absorbable spacers if needed
- Availability of Digital Imaging and Communications in Medicine (DICOM) images from previous treatment
- Written informed consent
- Ability to understand the trial's characteristics and consequences
You will not qualify if you...
- Presence of hip prosthesis, metal prostheses, or any condition preventing adequate imaging for treatment planning
- Intestinal infiltration
- Bladder infiltration
- Vessel infiltration
- Previous therapy with anti-angiogenesis drugs
- Psychiatric or other disorders preventing informed consent
- Previous invasive tumor except non-melanoma skin cancer unless disease-free for at least 3 years
- Use of absorbable spacers (e.g., vycril)
- Tumor located less than 10 mm from the small intestine as shown by imaging
- Inability to undergo MRI assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CNAO
Pavia, Pv, Italy, 27100
Actively Recruiting
Research Team
A
Amelia Barcellini, MD
CONTACT
C
Cristina Bono, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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