Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Patient's ability to understand the characteristics and consequences of the clinical trial Who Should NOT Join This Trial: - 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 willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

RADIATION

carbon ion radiation therapy

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.

Locations (1)

CNAO
Pavia, Pv, Italy