Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Recruiting now · Not applicable
Conditions studied: Tumor Recurrence, Malignant Epithelial Neoplasm of Vulva, Malignant Epithelial Tumor of Ovary, Malignant Epithelial Neoplasm
In brief
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).
Key facts
- Study ID
- NCT05457595
- Run by
- CNAO National Center of Oncological Hadrontherapy
- People needed
- 55
- Starts
- 2021-02-24
- Expected to finish
- 2028-02-25
- Last updated by the study team
- 2025-08-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CNAO — Pavia, Pv, Italy (enrolling)
Full record on ClinicalTrials.gov
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