Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies (NCT05457595) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
Italy55 participantsStarted 2021-02-24
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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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),…
What they're measuring
1
local control
Timeframe: 1 year after treatment
2
complete response
Timeframe: 1 year after treatment
3
partial response
Timeframe: 1 year after treatment
4
stable disease
Timeframe: 1 year after treatment
5
progression disease
Timeframe: 1 year after treatment
Trial details
NCT IDNCT05457595
SponsorCNAO National Center of Oncological Hadrontherapy