Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- complete response
Study Overview
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:
- To describe the safety profile of carbon ion therapy.
- To estimate the effect, in terms of survival, of carbon ion treatment
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
carbon ion radiotherapy
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.
Intervention: carbon ion radiation therapy (Radiation)
Outcomes
Primary Outcomes
complete response
Time Frame: 1 year after treatment
complete regression of the tumor lesion
partial response
Time Frame: 1 year after treatment
Reduction of the tumor volume \> 65% of the initial volume
progression disease
Time Frame: 1 year after treatment
Volume increase \> 73% of the initial volume.
local control
Time Frame: 1 year after treatment
absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies
stable disease
Time Frame: 1 year after treatment
Volume between PR and PD
Secondary Outcomes
- overall survival(1 year after treatment)
- Progression free survival(1 year after treatment)
- Toxicity assessment according to CTCAE v. 5(1 year after treatment)