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

Sponsor

CNAO National Center of Oncological Hadrontherapy (Other)

Overall Status

Recruiting

CT.gov ID

NCT05457595

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Tumor Recurrence Malignant Epithelial Neoplasm of Vulva Malignant Epithelial Tumor of Ovary Malignant Epithelial Neoplasm	Radiation: carbon ion radiation therapy	N/A

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:

To describe the safety profile of carbon ion therapy.
To estimate the effect, in terms of survival, of carbon ion treatment

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 24, 2021

Anticipated Primary Completion Date :

Feb 24, 2025

Anticipated Study Completion Date :

Feb 25, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

local control [1 year after treatment]
absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies
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
stable disease [1 year after treatment]
Volume between PR and PD
progression disease [1 year after treatment]
Volume increase > 73% of the initial volume.

Secondary Outcome Measures

overall survival [1 year after treatment]
overall survival
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)
Progression free survival [1 year after treatment]
Progression free survival (PFS) with qualitative evaluation as a narrative of progression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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