Malignant MelanomaCYCLENCT05478876
Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
A study testing carbon ion radiation therapy CIRT in people with Malignant Melanoma and Gynecologic Cancer, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
Trial summary
The present monocentric prospective phase 2 study aims to reproduce the results obtained at NIRS thus offering the possibility of obtaining a promising rate of progression-free survival (PFS) and local control (LC) in patients diagnosed with mucosal melanoma of lower genital tract. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Malignant Melanoma, Gynecologic Cancer
- What is being tested?
- carbon ion radiation therapy CIRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 3 Sep 2020to Sep 2027
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis
- Absence of skin extension
- N + (only if confined to the groin and pelvis)
- Age between 20-80 years
- ECOG 0-2
- No evidence of metastasis
Show all 12Show fewer
- At least 5 mm away with rectum and bladder wall
- No previous RT
- Written informed consent
- Patient's ability to understand the characteristics and consequences of the clinical trial
- Molecular characterization/ mutational state
- Disease staging (baseline exams)
Who cannot join
- Hip prosthesis, or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan
- Psychic or other disorders that may prevent informed consent
- Previous invasive tumor unless patient has been disease free for at least 3 years
- Contraindication to MRI
- Pregnancy or breastfeeding in progress
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, 27100
Cristina Bono, MSc, 0382078613, cristina.bono@cnao.it
About this study
Official title: CNAO 40-2020 C CYCLE "Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract" "Radioterapia Con Ioni Carbonio Per il Trattamento Dei Melanomi Mucosi Ginecologici"
The present monocentric prospective phase 2 study aims to reproduce the results obtained at NIRS thus offering the possibility of obtaining a promising rate of progression-free survival (PFS) and local control (LC) in patients diagnosed with mucosal melanoma of lower genital tract. Systemic treatment with immunotherapy is not the subject of this study but is allowed both in the neoadjuvant and sequential regimens.
Melanomas have always been considered poorly radiosensitive. It is now accepted that high LET (Linear Energy Transfer) particle beams, such as carbon ions, can offer a biological advantage, compared to photons treatment, in radio-resistant neoplasms treatment, thanks to their higher biological efficacy (RBE) against tumours with a low α/ ß ratio. In addition, carbon ions have the physical advantage of an inverted depth deposition profile compared to photons, allowing then a steep dose gradients that ensure increased sparing of adjacent healthy organs at risk (OARs).
Read the detailed description
Patients with primary gynaecological melanoma, non-metastatic, non-suitable for surgery, and not previously subjected to conventional radiotherapy can be enrolled in the trial, according to selection criteria. After requested baseline exams, the patient undergoes to simulation phase for the carbon ion radiation therapy, according to study constraints. The patient will then receive immunotherapy not concomitant to CIRT. The response is evaluated through RECIST criteria.
PFS is the primary endpoint, calculated from the end of CIRT to date of disease progression or death or last follow up.
- Conditions
- Malignant Melanoma, Gynecologic Cancer
- Being tested
- carbon ion radiation therapy CIRT
- Keywords
- hadrontherapy, gynecological melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon ion radiation therapy CIRTRadiation
Also called immunotherapy
CIRT: The low-dose CTV (clinical target volume) will receive a total dose of 43 GyRBE in 10 fractions, 4 fractions per week. The high-dose CTV will receive a total dose of 68.8 GyRBE in 16 fractions, 4 fractions per week.
The expected duration of treatment is 4 weeks, 4 fractions per week. Treatments lasting longer than 6 weeks, or with less than 6 fractions administered on 14 consecutive days, will not be considered acceptable.
Immunotherapy: Patients will undergo immunotherapy after carbon ion radiation therapy (CIRT) up to maximum response and/or up to tolerance. The concomitant association of immunotherapy is not envisaged in this protocol.
| Study group | Role | What they receive |
|---|---|---|
| carbon ion radiotherapy | Experimental | Patients affected by pelvic recurrence of gynecological cancer, who had not undergone to previous pelvic irradiation, will be enrolled on this study. After enrollment, patients undergo baseline exams, simulation CT and MRI and then carbon ion radiation therapy treatment will be performed, according to trial indications. Receives: Radiation: carbon ion radiation therapy CIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
estimate 2-year PFS in patients diagnosed with mucosal melanoma of the lower genital tract, treated with carbon ion radiation therapy.
Measured: 2 years
Secondary outcomes (5)
Overall survival (OS)
The OS will be calculated from the end date of therapy with carbon ion radiation
Measured: 3 years
Toxicity according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
acute, medium term and late toxicity
Measured: within 3 months, 3-6 months, over 6 months from CIRT
local response
according to Response Evaluation Criteria in Solid Tumours RECIST 1.1
Measured: 3 years
assessment of quality of life
assessed through questionarie Portec 3 administered on each follow up
Measured: 3 years
assessment of quality of life for >= 75 years old patients
assessed through questionnaire G8 Geriatric questionnaire administered on each follow up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start3 Sep 2020
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies 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
- cohort of 9 patients with primary gynecological melanoma. The intervention consists in carbon ion radiation therapy. The expected duration of treatment is 4 weeks, 4 fractions per week.
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT05478876
- Sponsor's protocol ID
- CNAO 40-2020 C CYCLE
- Acronym
- CYCLE
- Status last verified
- Aug 2024
- First submitted
- 29 Dec 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CNAO 40-2020 C CYCLE "Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract" "Radioterapia Con Ioni Carbonio Per il Trattamento Dei Melanomi Mucosi Ginecologici"
- ClinicalTrials.gov ID
- NCT05478876
- Acronym / sponsor ID
- CYCLE / CNAO 40-2020 C CYCLE
- Conditions
- Malignant Melanoma, Gynecologic Cancer
- Keywords
- hadrontherapy, gynecological melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 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 present monocentric prospective phase 2 study aims to reproduce the results obtained at NIRS thus offering the possibility of obtaining a promising rate of progression-free survival (PFS) and local control (LC) in patients diagnosed with mucosal melanoma of lower genital tract. Systemic treatment with immunotherapy is not the subject of this study but is allowed both in the neoadjuvant and sequential regimens.
Melanomas have always been considered poorly radiosensitive. It is now accepted that high LET (Linear Energy Transfer) particle beams, such as carbon ions, can offer a biological advantage, compared to photons treatment, in radio-resistant neoplasms treatment, thanks to their higher biological efficacy (RBE) against tumours with a low α/ ß ratio. In addition, carbon ions have the physical advantage of an inverted depth deposition profile compared to photons, allowing then a steep dose gradients that ensure increased sparing of adjacent healthy organs at risk (OARs).
Detailed description
Patients with primary gynaecological melanoma, non-metastatic, non-suitable for surgery, and not previously subjected to conventional radiotherapy can be enrolled in the trial, according to selection criteria. After requested baseline exams, the patient undergoes to simulation phase for the carbon ion radiation therapy, according to study constraints. The patient will then receive immunotherapy not concomitant to CIRT. The response is evaluated through RECIST criteria.
PFS is the primary endpoint, calculated from the end of CIRT to date of disease progression or death or last follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cohort of 9 patients with primary gynecological melanoma. The intervention consists in carbon ion radiation therapy. The expected duration of treatment is 4 weeks, 4 fractions per week.
| Arm | Type | Receives |
|---|---|---|
| carbon ion radiotherapy | Experimental | Radiation: carbon ion radiation therapy CIRTPatients affected by pelvic recurrence of gynecological cancer, who had not undergone to previous pelvic irradiation, will be enrolled on this study. After enrollment, patients undergo baseline exams, simulation CT and MRI and then carbon ion radiation therapy treatment will be performed, according to trial indications. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histological diagnosis
- Absence of skin extension
- N + (only if confined to the groin and pelvis)
- Age between 20-80 years
- ECOG 0-2
Key exclusion criteria (5 listed)
- Hip prosthesis, or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan
- Psychic or other disorders that may prevent informed consent
- Previous invasive tumor unless patient has been disease free for at least 3 years
- Contraindication to MRI
- Pregnancy or breastfeeding in progress
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 therapy CIRTAlso: immunotherapyCIRT: The low-dose CTV (clinical target volume) will receive a total dose of 43 GyRBE in 10 fractions, 4 fractions per week. The high-dose CTV will receive a total dose of 68.8 GyRBE in 16 fractions, 4 fractions per week. The expected duration of treatment is 4 weeks, 4 fractions per week. Treatments lasting longer than 6 weeks, or with less than 6 fractions administered on 14 consecutive days, will not be considered acceptable. Immunotherapy: Patients will undergo immunotherapy after carbon ion radiation therapy (CIRT) up to maximum response and/or up to tolerance. The concomitant association of immunotherapy is not envisaged in this protocol. | Radiation | carbon ion radiotherapy |
Primary outcome
progression free survival
Time frame: 2 years
estimate 2-year PFS in patients diagnosed with mucosal melanoma of the lower genital tract, treated with carbon ion radiation therapy.
5 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Toxicity according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Time frame: within 3 months, 3-6 months, over 6 months from CIRT
local response
Time frame: 3 years
assessment of quality of life
Time frame: 3 years
assessment of quality of life for >= 75 years old patients
Time frame: 3 years
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 21 Aug 2024.
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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 CIRT in people with Malignant Melanoma and Gynecologic Cancer, 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 5 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 21 Aug 2024. 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 (0039 0382078501, amelia.barcellini@cnao.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 2 years). 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 21 Aug 2024.