Endometrial CancerNCT04251676
Radiation Therapy in Uterine Cancer: Dosimetry Analysis, Clinical Implication, and Survival Analysis
An observational study of Endometrial Cancer, run by National Taiwan University Hospital.
Trial summary
We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis. Read more about this study
- Who is it for?
- Ages 20 to 100 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Observational study
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Dec 2021
- Phase
- Observational
- 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 20 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with uterine cancer (stage I - IV) treated in National Taiwan University Hospital, from January 2010 to September 2019.
Who may be able to join
- Women with uterine cancer (stage I - IV) treated in National Taiwan University Hospital, from January 2010 to September 2019.
Who cannot join
- Women with uterine cancer (stage I - IV) NOT treated in National Taiwan University Hospital, from January 2010 to September 2019.
About this study
We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.
Read the detailed description
We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.
- Conditions
- Endometrial Cancer
- Being tested
- Observational study
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival: The time from inclusion to documented disease progression according to RECIST v1.1 or death from any cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2010
- Primary completion30 Sep 2019
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251676
- Sponsor's protocol ID
- 201910019RINA
- Status last verified
- Jan 2021
- First submitted
- 30 Jan 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen JL, Huang YS, Huang CY, Hsu CY, Lan KH, Cheng WF, Kuo SH. Impact of adjuvant radiotherapy on the survival of women with optimally resected stage III endometrial cancer in the era of modern radiotherapy: a retrospective study. Radiat Oncol. 2020 Apr 6;15(1):72. doi: 10.1186/s13014-020-01523-5.
PubMed 32252781
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy in Uterine Cancer: Dosimetry Analysis, Clinical Implication, and Survival Analysis
- ClinicalTrials.gov ID
- NCT04251676
- Acronym / sponsor ID
- 201910019RINA
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 5 Feb 2020 (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.
We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.
Detailed description
We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with uterine cancer (stage I - IV) treated in National Taiwan University Hospital, from January 2010 to September 2019.
Key inclusion criteria (1 listed)
- Women with uterine cancer (stage I - IV) treated in National Taiwan University Hospital, from January 2010 to September 2019.
Key exclusion criteria (1 listed)
- Women with uterine cancer (stage I - IV) NOT treated in National Taiwan University Hospital, from January 2010 to September 2019.
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 |
|---|---|---|
| Observational studyObservational study | Other | – |
Primary outcome
Progression free survival
Time frame: 5 years
Progression free survival: The time from inclusion to documented disease progression according to RECIST v1.1 or death from any cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 32252781Chen JL, Huang YS, Huang CY, Hsu CY, Lan KH, Cheng WF, Kuo SH. Impact of adjuvant radiotherapy on the survival of women with optimally resected stage III endometrial cancer in the era of modern radiotherapy: a retrospective study. Radiat Oncol. 2020 Apr 6;15(1):72. doi: 10.1186/s13014-020-01523-5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by National Taiwan University Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Feb 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?
Results are not available in the source record.
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?
Progression free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251676, which also lists 1 linked publication.
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 11 Feb 2021.