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

Tumor Recurrence Clinical Trial

— CYCLOPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457595
• Other study ID #: CNAO 41 2020C
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: February 25, 2025

Study information

• Verified date: July 2022
• Source: CNAO National Center of Oncological Hadrontherapy
• Contact: Amelia Barcellini, MD
• Phone: 390382075501
• Email: amelia.barcellini[@]cnao.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: February 25, 2025
• Est. primary completion date: February 24, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Malignant Epithelial Neoplasm
• Neoplasms
• Neoplasms, Glandular and Epithelial
• Recurrence
• Tumor Recurrence

Intervention

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.

Locations

Country	Name	City	State
Italy	CNAO	Pavia	Pv

Sponsors (1)

Lead Sponsor	Collaborator
CNAO National Center of Oncological Hadrontherapy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local control	absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies	1 year after treatment
Primary	complete response	complete regression of the tumor lesion	1 year after treatment
Primary	partial response	Reduction of the tumor volume > 65% of the initial volume	1 year after treatment
Primary	stable disease	Volume between PR and PD	1 year after treatment
Primary	progression disease	Volume increase > 73% of the initial volume.	1 year after treatment
Secondary	overall survival	overall survival	1 year after treatment
Secondary	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
Secondary	Progression free survival	Progression free survival (PFS) with qualitative evaluation as a narrative of progression	1 year after treatment