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

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).

Eligibility

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

Conditions5

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