Cervical CancerNCT05141825
Proton and Carbon Ion Radiotherapy for Cervical Cancer
A study testing proton and carbon ion radiotherapy in people with Cervical Cancer, run by Shanghai Proton and Heavy Ion Center.
Trial summary
The aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- proton and carbon ion radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- . histologically diagnosis of squamous cell carcinoma of the cervix;
- . International Federation of Gynecology and Obstetrics (FIGO) stage (2014) IB2 - IIIB, without rectum invasion; or FIGO stage IA - IB1, who refused surgery or were contraindication for surgery due to comorbidity diseases;
- . received proton and carbon ion radiotherapy (PCRT) with or without chemotherapy for curative intention;
- . Follow-up data available.
Who cannot join
- a previous history of other malignancy;
- squamous cell carcinoma of the cervix patients who had received surgery;
- rectum was invaded.
About this study
Official title: Proton and Carbon Ion Radiotherapy for Cervical Cancer : A Retrospective Analysis
The aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for cervical cancer.
Read the detailed description
To retrospectively analyze cervical cancer patients received radical proton and carbon radiotherapy in our center. The acute and late toxicities, overall survival (OS), local control rate (LC), progression-free survival (PFS) and distant metastasis-free survival (DMFS) were analyzed.
- Conditions
- Cervical Cancer
- Being tested
- proton and carbon ion radiotherapy
- Keywords
- proton and carbon ion radiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton and carbon ion radiotherapyRadiation
proton and carbon ion radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| proton and carbon ion radiotherapy | Experimental | proton and carbon ion radiotherapy Receives: Radiation: proton and carbon ion radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
overall survival rate
overall survival rate
Measured: 3 years
local control rate
local control rate
Measured: 3 years
progression-free survival
progression-free survival
Measured: 3 years
distant metastasis-free survival
distant metastasis-free survival
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 posted2 Dec 2021
- Study start1 Jan 2016
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhan Yu, Shanghai Proton and Heavy Ion Center
- Investigators
- Qing Zhang, MD, Principal investigator, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141825
- Sponsor's protocol ID
- SPHIC-TR-CERC-2021-01
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton and Carbon Ion Radiotherapy for Cervical Cancer : A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05141825
- Acronym / sponsor ID
- SPHIC-TR-CERC-2021-01
- Conditions
- Cervical Cancer
- Keywords
- proton and carbon ion radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 2 Dec 2021 (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 aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for cervical cancer.
Detailed description
To retrospectively analyze cervical cancer patients received radical proton and carbon radiotherapy in our center. The acute and late toxicities, overall survival (OS), local control rate (LC), progression-free survival (PFS) and distant metastasis-free survival (DMFS) were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proton and carbon ion radiotherapy | Experimental | Radiation: proton and carbon ion radiotherapyproton and carbon ion radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . histologically diagnosis of squamous cell carcinoma of the cervix;
- . International Federation of Gynecology and Obstetrics (FIGO) stage (2014) IB2 - IIIB, without rectum invasion; or FIGO stage IA - IB1, who refused surgery or were contraindication for surgery due to comorbidity diseases;
- . received proton and carbon ion radiotherapy (PCRT) with or without chemotherapy for curative intention;
- . Follow-up data available.
Key exclusion criteria (3 listed)
- a previous history of other malignancy;
- squamous cell carcinoma of the cervix patients who had received surgery;
- rectum was invaded.
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 |
|---|---|---|
| proton and carbon ion radiotherapyproton and carbon ion radiotherapy | Radiation | proton and carbon ion radiotherapy |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
4 secondary outcomes
overall survival rate
Time frame: 3 years
local control rate
Time frame: 3 years
progression-free survival
Time frame: 3 years
distant metastasis-free survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Qing Zhang, MD principal investigator
Shanghai Proton and Heavy Ion Center
Questions about this trial
What is this clinical trial studying?
A study testing proton and carbon ion radiotherapy in people with Cervical Cancer, run by Shanghai Proton and Heavy Ion Center.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: through study completion, an average of 1 year). 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 2 Dec 2021.