MedTrace Logo

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

NCT05457595 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-08-06

No results posted yet for this study

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).

Conditions

  • Tumor Recurrence
  • Malignant Epithelial Neoplasm of Vulva
  • Malignant Epithelial Tumor of Ovary
  • Malignant Epithelial Neoplasm

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.

Sponsors & Collaborators

  • CNAO National Center of Oncological Hadrontherapy

    lead OTHER

Principal Investigators

  • Amelia Barcellini, MD · CNAO National Center of Oncological Hadrontherapy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2028-02-24
Completion
2028-02-25

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457595 on ClinicalTrials.gov