Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies

Conditions
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Tumor Recurrence, Malignant Epithelial Neoplasm of Vulva, Malignant Epithelial Tumor of Ovary, Malignant Epithelial Neoplasm

Intervention / Treatment
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* Radiation: carbon ion radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carbon ion radiotherapy<br>All enrolled subjects will undergo carbon ion radiation therapy. Patients affected by pelvic recurrence of gynecological neoplasia, already undergone to radiotherapy on pelvis, will be enrolled in the study. | Radiation: carbon ion radiation therapy<br>* 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.<br>* Other names: CIRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control | absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies | 1 year after treatment | 
| complete response | complete regression of the tumor lesion | 1 year after treatment | 
| partial response | Reduction of the tumor volume > 65% of the initial volume | 1 year after treatment | 
| stable disease | Volume between PR and PD | 1 year after treatment | 
| progression disease | Volume increase > 73% of the initial volume. | 1 year after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival | 1 year after treatment | 
| 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) | 1 year after treatment | 
| Progression free survival | Progression free survival (PFS) with qualitative evaluation as a narrative of progression | 1 year after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gynecological cancer, carbon ion radiation therapy, recurrencies, CIRT