Malignant Epithelial Neoplasm, Malignant Epithelial Neoplasm of Vulva, Malignant Epithelial Tumor of Ovary, Tumor Recurrence
Conditions
Keywords
gynecological cancer, carbon ion radiation therapy, recurrencies, CIRT
Brief 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).
Detailed 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: 1. To describe the safety profile of carbon ion therapy. 2. To estimate the effect, in terms of survival, of carbon ion treatment
Interventions
RADIATIONcarbon 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.
Sponsors
CNAO National Center of Oncological Hadrontherapy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression disease | 1 year after treatment | Volume increase \> 73% of the initial volume. |
| 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 |
| local control | 1 year after treatment | absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity assessment according to CTCAE v. 5 | 1 year after treatment | Tto define acute, intermediate and late toxicities according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0) |
| Progression free survival | 1 year after treatment | Progression free survival (PFS) with qualitative evaluation as a narrative of progression |
| overall survival | 1 year after treatment | overall survival |
Countries
Italy
Contacts
Primary ContactAmelia Barcellini, MD
Backup ContactCristina Bono, MSc
Outcome results
None listed