NCT05457595Recruiting
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Source: ClinicalTrials.gov · Last updated 6 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 11 Jul 2022
- Start date
- 24 Feb 2021
- Primary completion date
- 24 Feb 2028
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Diseases
- Ovarian cancer
- NCT number
- NCT05457595
What you commit to
- Study type: Interventional
- Planned participants: 55
- From 24 Feb 2021 to the primary completion date, 24 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan
- Intestinal infiltration
- Bladder infiltration
- Vessel infiltration
- Previous therapy with anti-angiogenesis drugs
- Psychic or other disorders that may prevent informed consent
- Previous invasive tumor, with the exception of skin cancer (excluding melanoma) unless disease-free for at least 3 years
- Spacer in absorbable material (i.e. vycril)
- Distance \< 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated
- Impossibility to assess MRI
Who the study is looking for
- Patients ≥ 18 years of age
- Karnofsky Index ≥ 70
- Histological or radiological diagnosis of pelvic and groin recurrence
- Contraindications for radical surgery
- No other distant progression or stable disease (SD) of known secondarisms (≥6 months)
- Previous radiation therapy on pelvis
- Distance ≥ 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated
- Possibility to perform a surgery to space the intestinal loops, in case of distance \< 10mm
- If needed, spacer in biocompatible material (silicon, goretex) or anatomical material (omentum, muscle patch), non-absorbable.
- DICOM (Digital Imaging and COmmunications in Medicine) images of the previous treatment plan availability
- Written informed consent
- Patient's ability to understand the characteristics and consequences of the clinical trial
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CNAO Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.