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

RecruitingNAAges 18 Years - anyFemaleCNAO National Center of Oncological Hadrontherapy
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients โ‰ฅ 18 years of age * Karnofsky Index โ‰ฅ 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 (โ‰ฅ6 months) * Previous radiation therapy on pelvis * Distance โ‰ฅ 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
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What it tests

  • carbon ion radiation therapy
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Where

1 site
CNAO
Pavia, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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