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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Tumor Recurrence; Malignant Epithelial Neoplasm of Vulva; Malignant Epithelial Tumor of Ovary; Malignant Epithelial Neoplasm
• Intervention / Treatment: Radiation: carbon ion radiation therapy

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 Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amelia Barcellini, MD; Phone Number: 390382075501; Email: amelia.barcellini@cnao.it
• Study Contact Backup: Name: Cristina Bono, MSc; Phone Number: 390382075613; Email: cristina.bono@cnao.it

Study Locations

• Italy
  • Pv
    • Pavia, Pv, Italy, 27100
      • Recruiting
      • CNAO
      • Contact: Cristina Bono, MSc; Phone Number: 0382078613; Email: cristina.bono@cnao.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: CIRT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CNAO National Center of Oncological Hadrontherapy
• Investigators: Principal Investigator: Amelia Barcellini, MD, CNAO National Center of Oncological Hadrontherapy

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Estimated): February 24, 2028
• Study Completion (Estimated): February 25, 2028

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: gynecological cancer; carbon ion radiation therapy; CIRT; recurrencies
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Neoplasms; Recurrence; Carcinoma; Ovarian Neoplasms; Neoplasms, Glandular and Epithelial
• Other Study ID Numbers: CNAO 41 2020C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No