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

NCT05457595 | Recruiting

• 1 other identifier: CNAO 41 2020C
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

gynecological cancer; carbon ion radiation therapy; recurrencies; CIRT

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• overall survival

  1 year after treatment

• Toxicity assessment according to CTCAE v. 5

  1 year after treatment

• Progression free survival

  1 year after treatment

Study Arms (1)

carbon ion radiotherapy

EXPERIMENTAL

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

Interventions

carbon ion radiation therapy RADIATION

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.

Also known as: CIRT

carbon ion radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The research applies to gynecological tumors.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CNAO National Center of Oncological Hadrontherapy: lead

Study Sites (1)

CNAO

Pavia, Pv, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Recurrence; Vulvar Neoplasms; Ovarian Neoplasms; Carcinoma

Interventions

Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Amelia Barcellini, MD

  CNAO National Center of Oncological Hadrontherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelia Barcellini, MD

CONTACT

390382075501; amelia.barcellini@cnao.it

Cristina Bono, MSc

CONTACT

390382075613; cristina.bono@cnao.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: February 24, 2021
• Primary Completion (Estimated): February 24, 2028
• Study Completion (Estimated): February 25, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

IT (1)