About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years of age
Karnofsky Index ≥ 70
Histological or radiological diagnosis of pelvic and groin recurrence
Contraindications for radical surgery
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
carbon ion radiation therapy
RadiationCIRT: Planning Target Volume (PTV) will be delivered a total dose of 48-52.8 GyRBE in 12 fractions, 4 fractions per week. Treatment duration 3 weeks. Treatment lasting more than 5 weeks or cases of treatment with less than 6 fractions in 14 consecutive days will not be accepted.
Treatment groups
Trial outcomes
Primary outcomes
local control
absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies
complete response
complete regression of the tumor lesion
partial response
Reduction of the tumor volume \> 65% of the initial volume
stable disease
Volume between PR and PD
Secondary outcomes
overall survival
overall survival
Toxicity assessment according to CTCAE v. 5
Tto define acute, intermediate and late toxicities according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Progression free survival
Progression free survival (PFS) with qualitative evaluation as a narrative of progression
Sponsors and contacts
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