Endometrial CancerNCT05876130
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer
A study testing POHIM_EM in people with Endometrial Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To investigate the non-inferiority of disease-free survival in women who received hypofractionated intensity-modulated whole pelvic radiation therapy (2.5 Gy x 16 fractions) after curative surgery for stage III endometrial cancer. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- POHIM_EM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2022to 31 Dec 2031
- 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
- histologically confirmed endometrioid type endometrial cancer
- completion of hysterectomy and surgical staging
- pathologically confirmed FIGO stage III
- ECOG performance status 0 or 1
- adjuvant chemotherapy was done or planned
Who cannot join
- presence of distant metastasis
- previous history of pelvic radiotherapy
- severe and unstable medical condition
- previous history of other carcinoma except for thyroid cancer, skin cancer, and endometrial cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Won Kyung Cho contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Won Park, wonro.park@samsung.com
About this study
Official title: Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)
To investigate the non-inferiority of disease-free survival in women who received hypofractionated intensity-modulated whole pelvic radiation therapy (2.5 Gy x 16 fractions) after curative surgery for stage III endometrial cancer.
- Conditions
- Endometrial Cancer
- Being tested
- POHIM_EM
- Keywords
- radiation therapy, hypofractionation
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POHIM_EMRadiation
hypofractionated intensity-modulated radiation therapy (2.5 Gy/fraction, 16 fractions)
| Study group | Role | What they receive |
|---|---|---|
| POHIM_EM | Experimental | adjuvant hypofractionated IMRT for endometrial cancer Receives: Radiation: POHIM_EM |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year disease-free survival rate
disease-free survival rate after the time of surgery
Measured: 5 years
Secondary outcomes (2)
acute toxicities
acute toxicities within 3 months according to CTCAE v5.0
Measured: 3 months
late toxicities
late toxicities according to CTCAE v5.0
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 posted25 May 2023
- Study start1 Nov 2022
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (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 Samsung Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- hypofractionated IMRT (2.5 Gy x 16 fractions)
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Park, Samsung Medical Center
- Investigators
- Won Park, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876130
- Sponsor's protocol ID
- 2022-09-123
- Status last verified
- Jun 2024
- First submitted
- 16 May 2023
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)
- ClinicalTrials.gov ID
- NCT05876130
- Acronym / sponsor ID
- 2022-09-123
- Conditions
- Endometrial Cancer
- Keywords
- radiation therapy, hypofractionation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 25 May 2023 (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 investigate the non-inferiority of disease-free survival in women who received hypofractionated intensity-modulated whole pelvic radiation therapy (2.5 Gy x 16 fractions) after curative surgery for stage III endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- hypofractionated IMRT (2.5 Gy x 16 fractions)
| Arm | Type | Receives |
|---|---|---|
| POHIM_EM | Experimental | Radiation: POHIM_EMadjuvant hypofractionated IMRT for endometrial cancer |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically confirmed endometrioid type endometrial cancer
- completion of hysterectomy and surgical staging
- pathologically confirmed FIGO stage III
- ECOG performance status 0 or 1
- adjuvant chemotherapy was done or planned
Key exclusion criteria (4 listed)
- presence of distant metastasis
- previous history of pelvic radiotherapy
- severe and unstable medical condition
- previous history of other carcinoma except for thyroid cancer, skin cancer, and endometrial cancer
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 |
|---|---|---|
| POHIM_EMhypofractionated intensity-modulated radiation therapy (2.5 Gy/fraction, 16 fractions) | Radiation | POHIM_EM |
Primary outcome
5-year disease-free survival rate
Time frame: 5 years
disease-free survival rate after the time of surgery
2 secondary outcomes
acute toxicities
Time frame: 3 months
late toxicities
Time frame: 5 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 12 Jun 2024.
- 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.
Won Kyung Cho contact
Won Park principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POHIM_EM in people with Endometrial Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 4 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 12 Jun 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 South Korea. 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 Won Park (+82-2-3410-2612, wonro.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year disease-free survival rate (time frame: 5 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 12 Jun 2024.