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

Not Applicable

Recruiting

• Conditions: Malignant Epithelial Neoplasm of Vulva; Tumor Recurrence; Malignant Epithelial Tumor of Ovary; Malignant Epithelial Neoplasm

• Registration Number: NCT05457595
• Lead Sponsor: CNAO National Center of Oncological Hadrontherapy

Brief 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).

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

Study Timeline

• Study Start: 2021-02-24
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-14
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-06
• Primary Completion: 2028-02-24
• Study Completion: 2028-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
complete response	1 year after treatment	complete regression of the tumor lesion
partial response	1 year after treatment	Reduction of the tumor volume \> 65% of the initial volume
progression disease	1 year after treatment	Volume increase \> 73% of the initial volume.
local control	1 year after treatment	absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies
stable disease	1 year after treatment	Volume between PR and PD

Secondary Outcome Measures

Name	Time	Method
Progression free survival	1 year after treatment	Progression free survival (PFS) with qualitative evaluation as a narrative of progression
Toxicity assessment according to CTCAE v. 5	1 year after treatment	Tto define acute, intermediate and late toxicities according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
overall survival	1 year after treatment	overall survival

Trial Locations

Locations (1)

CNAO; 🇮🇹 Pavia, Pv, Italy