Tumor RecurrenceMalignant Epithelial Neoplasm of VulvaMalignant Epithelial Tumor of OvaryMalignant Epithelial Neoplasm
Investigational drug(s) / intervention(s)
carbon ion radiation therapy
carbon ion radiation therapy: CIRT: 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.
Study summary
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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
local control — 1 year after treatment absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies
complete response — 1 year after treatment complete regression of the tumor lesion
partial response — 1 year after treatment Reduction of the tumor volume \> 65% of the initial volume
stable disease — 1 year after treatment Volume between PR and PD
progression disease — 1 year after treatment Volume increase \> 73% of the initial volume.
Trial sites (1)
Facility
City
Region
Status
CNAO
Pavia
Pv
Recruiting
More CNAO National Center of Oncological Hadrontherapy trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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