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Recruiting NCT05457595

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

No phase Interventional Tumor Recurrence Malignant Epithelial Neoplasm of Vulva Malignant Epithelial Tumor of Ovary Malignant Epithelial Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: carbon ion radiation therapy.
Who it may be relevant to
Registry conditions: Tumor Recurrence, Malignant Epithelial Neoplasm of Vulva, Malignant Epithelial Tumor of Ovary, Malignant Epithelial Neoplasm. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

Primary aim: estimate the effect, in terms of clinical response, of carbon ion treatment (CIRT) in patients with lateral pelvic recurrences of gynecological malignancies.

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

Interventions

  • 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.

Primary outcome measures

  • local control [Time frame: 1 year after treatment]
  • complete response [Time frame: 1 year after treatment]
  • partial response [Time frame: 1 year after treatment]
  • stable disease [Time frame: 1 year after treatment]
  • progression disease [Time frame: 1 year after treatment]
Secondary outcome measures (3)
  • overall survival [Time frame: 1 year after treatment]
  • Toxicity assessment according to CTCAE v. 5 [Time frame: 1 year after treatment]
  • Progression free survival [Time frame: 1 year after treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • CNAO — Pavia

Identifiers

NCT: NCT05457595 · CNAO 41 2020C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗