Endometrial CancerNCT04956601
Adjuvant Radiotherapy in Patients With Early Endometrial Cancer
A study testing vaginal brachytherapy/pelvic external beam radiotherapy in people with Endometrial Cancer and Pathology, run by Peking University Third Hospital at 1 site in China.
Trial summary
To compare the effect of vaginal brachytherapy as adjuvant treatment after operation when compared to pelvic external beam radiotherapy in patients with early endometrial cancer based on moderate risk molecules classification. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Pathology, Radiotherapy
- What is being tested?
- vaginal brachytherapy/pelvic external beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Jul 2021to Aug 2029
- 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
- Endometrial adenocarcinoma is confirmed by pathology, and the molecular types were microsatellite instability type and low copy type;
- Stage IA and grade 3 or stage IB (FIGO 2009), without substantial lymph-vascular space invasion;
- Surgery must have included a hysterectomy and bilateral adnexectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional;
- ECOG score is 0-2;
- The interval time between surgery and radiotherapy is no more than 8 weeks;
- The routine blood examination was normal;
- Compliance is good and informed consent is voluntarily signed.
Who cannot join
- The patients receive chemotherapy;
- History of previous malignant disease;
- Previous diagnosis of Crohn's disease or ulcerative colitis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Controlled Trial of Adjuvant Radiotherapy in Patients With Early Endometrial Cancer Based on Moderate Risk Molecules Classification
To compare the effect of vaginal brachytherapy as adjuvant treatment after operation when compared to pelvic external beam radiotherapy in patients with early endometrial cancer based on moderate risk molecules classification.
Read the detailed description
After being informed the study and potential risk，all patients giving written informed consent will be undergo a 1-week screening period determine eligibility for study entry. At week 0, patients who meet the eligibility will be randomized in a 1:1 ratio to vaginal brachytherapy or pelvic external beam radiotherapy. After treatment, patients were followed up regularly.
- Conditions
- Endometrial Cancer, Pathology, Radiotherapy
- Being tested
- vaginal brachytherapy/pelvic external beam radiotherapy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal brachytherapy/pelvic external beam radiotherapyRadiation
Also called Pelvic external beam radiotherapy
high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| VBT | Experimental | CT image guided high-dose-rate vaginal brachytherapy, 30Gy/6f, 2f/w. Receives: Radiation: vaginal brachytherapy/pelvic external beam radiotherapy |
| EBRT | Active comparator | Pelvic external beam radiotherapy，IMRT/VAMT，IGRT suggested，DT 45Gy/25f. Receives: Radiation: vaginal brachytherapy/pelvic external beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
disease-free survival from being received treatment
Measured: 5-year
Secondary outcomes (3)
Failure mode
vaginal recurrences; pelvic recurrence; distant metastases
Measured: 5-year
OS
Overall survival from being received treatment
Measured: 5-year
Toxicities
from being received treatment
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Wang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956601
- Sponsor's protocol ID
- ECART001
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial of Adjuvant Radiotherapy in Patients With Early Endometrial Cancer Based on Moderate Risk Molecules Classification
- ClinicalTrials.gov ID
- NCT04956601
- Acronym / sponsor ID
- ECART001
- Conditions
- Endometrial Cancer, Pathology, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 9 Jul 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.
To compare the effect of vaginal brachytherapy as adjuvant treatment after operation when compared to pelvic external beam radiotherapy in patients with early endometrial cancer based on moderate risk molecules classification.
Detailed description
After being informed the study and potential risk，all patients giving written informed consent will be undergo a 1-week screening period determine eligibility for study entry. At week 0, patients who meet the eligibility will be randomized in a 1:1 ratio to vaginal brachytherapy or pelvic external beam radiotherapy. After treatment, patients were followed up regularly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VBT | Experimental | Radiation: vaginal brachytherapy/pelvic external beam radiotherapyCT image guided high-dose-rate vaginal brachytherapy, 30Gy/6f, 2f/w. |
| EBRT | Active comparator | Radiation: vaginal brachytherapy/pelvic external beam radiotherapyPelvic external beam radiotherapy，IMRT/VAMT，IGRT suggested，DT 45Gy/25f. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Endometrial adenocarcinoma is confirmed by pathology, and the molecular types were microsatellite instability type and low copy type;
- Stage IA and grade 3 or stage IB (FIGO 2009), without substantial lymph-vascular space invasion;
- Surgery must have included a hysterectomy and bilateral adnexectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional;
- ECOG score is 0-2;
- The interval time between surgery and radiotherapy is no more than 8 weeks;
Key exclusion criteria (3 listed)
- The patients receive chemotherapy;
- History of previous malignant disease;
- Previous diagnosis of Crohn's disease or ulcerative colitis.
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 |
|---|---|---|
| vaginal brachytherapy/pelvic external beam radiotherapyAlso: Pelvic external beam radiotherapyhigh-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy | Radiation | EBRT, VBT |
Primary outcome
DFS
Time frame: 5-year
disease-free survival from being received treatment
3 secondary outcomes
Failure mode
Time frame: 5-year
OS
Time frame: 5-year
Toxicities
Time frame: 5-year
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 9 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal brachytherapy/pelvic external beam radiotherapy in people with Endometrial Cancer and Pathology, run by Peking University Third Hospital at 1 site in China.
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 7 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: opening soon, as of the sponsor's last update on 9 Jul 2021. 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 China. 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 Junjie Wang (861082265920, junjiewang_edu@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 5-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 9 Jul 2021.