Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
NCT ID: NCT05457595
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
55 participants
INTERVENTIONAL
2021-02-24
2028-02-25
Brief Summary
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Detailed Description
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Secondary aims:
1. To describe the safety profile of carbon ion therapy.
2. To estimate the effect, in terms of survival, of carbon ion treatment
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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CNAO National Center of Oncological Hadrontherapy
OTHER
Responsible Party
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Principal Investigators
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Amelia Barcellini, MD
Role: PRINCIPAL_INVESTIGATOR
CNAO National Center of Oncological Hadrontherapy
Locations
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CNAO
Pavia, Pv, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CNAO 41 2020C
Identifier Type: -
Identifier Source: org_study_id
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