Overview
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).
Description
Primary aim: estimate the effect, in terms of clinical response, of carbon ion treatment (CIRT) in patients with lateral pelvic recurrences of gynecological malignancies.
Secondary aims:
- To describe the safety profile of carbon ion therapy.
- To estimate the effect, in terms of survival, of carbon ion treatment
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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