Tumor RecurrenceCYCLOPSNCT05457595
Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
A study testing carbon ion radiation therapy in people with Tumor Recurrence and Malignant Epithelial Neoplasm of Vulva, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Tumor Recurrence, Malignant Epithelial Neoplasm of Vulva, Malignant Epithelial Tumor of Ovary
- What is being tested?
- carbon ion radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 24 Feb 2021to 25 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
CNAO
Pavia, Pv, 27100
Cristina Bono, MSc, 0382078613, cristina.bono@cnao.it
About this study
Official title: Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
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).
Read the 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
- Conditions
- Tumor Recurrence, Malignant Epithelial Neoplasm of Vulva, Malignant Epithelial Tumor of Ovary, Malignant Epithelial Neoplasm
- Being tested
- carbon ion radiation therapy
- Keywords
- gynecological cancer, carbon ion radiation therapy, recurrencies, CIRT
- Medical subject headings
- Recurrence, Vulvar Neoplasms, Ovarian Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon ion radiation therapyRadiation
Also called CIRT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: carbon ion radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control
absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies
Measured: 1 year after treatment
complete response
complete regression of the tumor lesion
Measured: 1 year after treatment
partial response
Reduction of the tumor volume > 65% of the initial volume
Measured: 1 year after treatment
stable disease
Volume between PR and PD
Measured: 1 year after treatment
progression disease
Volume increase > 73% of the initial volume.
Measured: 1 year after treatment
Secondary outcomes (3)
overall survival
overall survival
Measured: 1 year after treatment
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)
Measured: 1 year after treatment
Progression free survival
Progression free survival (PFS) with qualitative evaluation as a narrative of progression
Measured: 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start24 Feb 2021
- Primary completion24 Feb 2028 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amelia Barcellini, MD, Principal investigator, CNAO National Center of Oncological Hadrontherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457595
- Sponsor's protocol ID
- CNAO 41 2020C
- Acronym
- CYCLOPS
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2022
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT05457595
- Acronym / sponsor ID
- CYCLOPS / CNAO 41 2020C
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 24 Feb 2028 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrolled subjects will undergo to carbon ion radiation therapy. It is a monocentric, prospective II study.
| Arm | Type | Receives |
|---|---|---|
| carbon ion radiotherapy | Experimental | Radiation: carbon ion radiation therapyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbon ion radiation therapyAlso: CIRTCIRT: 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. | Radiation | carbon ion radiotherapy |
Primary outcome
local control
Time frame: 1 year after treatment
absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies
complete response
Time frame: 1 year after treatment
complete regression of the tumor lesion
partial response
Time frame: 1 year after treatment
Reduction of the tumor volume > 65% of the initial volume
stable disease
Time frame: 1 year after treatment
Volume between PR and PD
progression disease
Time frame: 1 year after treatment
Volume increase > 73% of the initial volume.
3 secondary outcomes
overall survival
Time frame: 1 year after treatment
Toxicity assessment according to CTCAE v. 5
Time frame: 1 year after treatment
Progression free survival
Time frame: 1 year after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amelia Barcellini, MD principal investigator
CNAO National Center of Oncological Hadrontherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon ion radiation therapy in people with Tumor Recurrence and Malignant Epithelial Neoplasm of Vulva, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelia Barcellini, MD (390382075501, amelia.barcellini@cnao.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control (time frame: 1 year after treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.