Back to results

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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

carbon ion radiation therapy

About this trial

This is an interventional treatment trial for Tumor Recurrence focused on measuring gynecological cancer, carbon ion radiation therapy, recurrencies, CIRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

CNAORecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

carbon ion radiotherapy

Arm 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.

Outcomes

Primary Outcome Measures

local control

absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies

complete response

complete regression of the tumor lesion

partial response

Reduction of the tumor volume > 65% of the initial volume

stable disease

Volume between PR and PD

progression disease

Volume increase > 73% of the initial volume.

Secondary Outcome Measures

overall survival

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)

Progression free survival

Progression free survival (PFS) with qualitative evaluation as a narrative of progression

Full Information

NCT ID

NCT05457595

First Posted

July 11, 2022

Last Updated

July 13, 2022

Sponsor

CNAO National Center of Oncological Hadrontherapy

1. Study Identification

Unique Protocol Identification Number

NCT05457595

Brief Title

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

Acronym

CYCLOPS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 24, 2021 (Actual)

Primary Completion Date

February 24, 2025 (Anticipated)

Study Completion Date

February 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CNAO National Center of Oncological Hadrontherapy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

gynecological cancer, carbon ion radiation therapy, recurrencies, CIRT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

carbon ion radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

carbon ion radiation therapy

Other Intervention Name(s)

CIRT

Intervention Description

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.

Primary Outcome Measure Information:

Title

local control

Description

absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies

Time Frame

1 year after treatment

Title

complete response

Description

complete regression of the tumor lesion

Time Frame

1 year after treatment

Title

partial response

Description

Reduction of the tumor volume > 65% of the initial volume

Time Frame

1 year after treatment

Title

stable disease

Description

Volume between PR and PD

Time Frame

1 year after treatment

Title

progression disease

Description

Volume increase > 73% of the initial volume.

Time Frame

1 year after treatment

Secondary Outcome Measure Information:

Title

overall survival

Description

overall survival

Time Frame

1 year after treatment

Title

Toxicity assessment according to CTCAE v. 5

Description

Tto define acute, intermediate and late toxicities according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

Time Frame

1 year after treatment

Title

Progression free survival

Description

Progression free survival (PFS) with qualitative evaluation as a narrative of progression

Time Frame

1 year after treatment

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

The research applies to gynecological tumors.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amelia Barcellini, MD

Phone

390382075501

amelia.barcellini@cnao.it

First Name & Middle Initial & Last Name or Official Title & Degree

Cristina Bono, MSc

Phone

390382075613

cristina.bono@cnao.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amelia Barcellini, MD

Organizational Affiliation

CNAO National Center of Oncological Hadrontherapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

CNAO

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cristina Bono, MSc

Phone

0382078613

cristina.bono@cnao.it

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs