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

CNAO National Center of Oncological Hadrontherapy

Status: Enrolling

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

Treatments: Radiation: carbon ion radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05457595

CNAO 41 2020C

Details and patient eligibility

About

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).

Full 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

Enrollment: 55 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

carbon ion radiotherapy

Experimental group

Description:

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.

Treatment:

Radiation: carbon ion radiation therapy