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
• Interventions: Radiation: carbon ion radiation therapy

• 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: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-02-24
• Study Completion: 2025-02-25

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

Arm && Interventions

Group	Intervention	Description
carbon ion radiotherapy	carbon ion radiation therapy	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.

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
overall survival	1 year after treatment	overall survival
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)

Trial Locations

Locations (1)

CNAO; 🇮🇹 Pavia, Pv, Italy