Endometrial CancerDeCRESCEndoNCT04386993
De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer
A study testing Intensity modulated radiation therapy in people with Endometrial Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of this study is to evaluate short course radiation in the post-operative female pelvis after hysterectomy in stage III-IVA endometrial adenocarcinoma patients, or any stage patients with uterine serous or carcinosarcoma histology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Intensity modulated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 13 Oct 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed stage IIIA-IVA endometrial cancer, or any stage I-IVA where any proportion of the tumor is uterine serous, clear cell, de-differentiated, or carcinosarcoma histology.
- Must have already undergone radical hysterectomy. Hysterectomy may have occurred no more than one year prior to enrollment.
- At least 18 years of age.
- ECOG performance status ≤ 2
- Minimal bone marrow and organ function as defined below:
- Leukocytes ≥ 1,000 cumm
Show all 10Show fewer
- Absolute neutrophil count ≥ 500 cumm
- Platelets ≥ 50,000 cumm
- Hemoglobin ≥ 7g/dL
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Prior radiation to the pelvis.
- Currently receiving any investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inflammatory bowel disease, or irritable bowel disease.
- Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)
The goal of this study is to evaluate short course radiation in the post-operative female pelvis after hysterectomy in stage III-IVA endometrial adenocarcinoma patients, or any stage patients with uterine serous or carcinosarcoma histology. The investigators hypothesize that short course pelvic radiation will have an acute and late grade 3-4 toxicity rate < 10%, and patients will benefit from both convenient and effective loco-regional control comparable to the traditional 5-6 weeks of radiation.
- Conditions
- Endometrial Cancer
- Being tested
- Intensity modulated radiation therapy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity modulated radiation therapyRadiation
Also called IMRT
Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays).
| Study group | Role | What they receive |
|---|---|---|
| IMRT | Experimental | -Five 5-Gy fractions of IMRT will be given to the pelvis with elective simultaneous boost to any suspicious lymph node or residual disease to 30 Gy.
-*Brachytherapy boost (at the discretion of the PI) within 2 weeks of radiation therapy completion. Once or twice weekly for three weeks Receives: Radiation: Intensity modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events
Measured: From start of radiation through Day 90
Incidence of late hematologic, gastrointestinal, and genitourinary adverse events
Measured: From Day 91 through month 12
Secondary outcomes (7)
Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE
- PRO-CTCAE responses are scored from 0 to 4 with 0=Never/Not at all/None and 4=Frequently/Very Much/Very Severe/Almost Constantly
- Scores for each attribute (frequency, severity and/or interference) will be presented descriptively
Measured: Baseline, 2 weeks, and 3 months post-completion of radiation
Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26
- Bladder has 7 questions and bowel has 9 questions
- The response for each item is standardized to a 0 to 100 scale
- The standardized values will be averaged for all items within a group to create the summary or subscale score.
Measured: Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
Change in quality of life as measured by FACT-En
- Questionnaire asking questions about physical well-being, social/family well-being, emotional well-being, functional well-being, and other additional concerns. Answers range from 0 = not at all to 4 = very much. Questions are phrased so that higher numbers indicate a better health state,
- Scoring is performed through a simple sum of item scores. Each subscale is scored, and a total score is obtained by adding each of the subscale scores.
Measured: Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
Locoregional control
-Locoregional recurrence is defined as histologic or radiographic evidence of cancer in the previously resected site or regional lymph nodes included in the radiated field.
Measured: Up to 12 months post-completion of radiation
Distant control
-Distant recurrence is defined as histologic or radiographic evidence of cancer outside of the radiated field.
Measured: Up to 12 months post-completion of radiation
Disease-free survival
-Disease-free survival is defined as survival with no evidence of disease recurrence or death
Measured: Up to 12 months post-completion of radiation
Overall survival
-Number of participants alive at the time of completion of follow-up
Measured: Up to 12 months post-completion of radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start7 Jul 2020
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
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 Washington University School of MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessika Contreras, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386993
- Sponsor's protocol ID
- 202004237
- Acronym
- DeCRESCEndo
- Status last verified
- Oct 2025
- First submitted
- 8 May 2020
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) for individual participant data meta-analysis by investigators whose proposed use of data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)
- ClinicalTrials.gov ID
- NCT04386993
- Acronym / sponsor ID
- DeCRESCEndo / 202004237
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 13 May 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.
The goal of this study is to evaluate short course radiation in the post-operative female pelvis after hysterectomy in stage III-IVA endometrial adenocarcinoma patients, or any stage patients with uterine serous or carcinosarcoma histology. The investigators hypothesize that short course pelvic radiation will have an acute and late grade 3-4 toxicity rate < 10%, and patients will benefit from both convenient and effective loco-regional control comparable to the traditional 5-6 weeks of radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT | Experimental | Radiation: Intensity modulated radiation therapy-Five 5-Gy fractions of IMRT will be given to the pelvis with elective simultaneous boost to any suspicious lymph node or residual disease to 30 Gy. -*Brachytherapy boost (at the discretion of the PI) within 2 weeks of radiation therapy completion. Once or twice weekly for three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed stage IIIA-IVA endometrial cancer, or any stage I-IVA where any proportion of the tumor is uterine serous, clear cell, de-differentiated, or carcinosarcoma histology.
- Must have already undergone radical hysterectomy. Hysterectomy may have occurred no more than one year prior to enrollment.
- At least 18 years of age.
- ECOG performance status ≤ 2
- Minimal bone marrow and organ function as defined below:
Key exclusion criteria (4 listed)
- Prior radiation to the pelvis.
- Currently receiving any investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inflammatory bowel disease, or irritable bowel disease.
- Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
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 |
|---|---|---|
| Intensity modulated radiation therapyAlso: IMRTRadiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays). | Radiation | IMRT |
Primary outcome
Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events
Time frame: From start of radiation through Day 90
Incidence of late hematologic, gastrointestinal, and genitourinary adverse events
Time frame: From Day 91 through month 12
7 secondary outcomes
Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE
Time frame: Baseline, 2 weeks, and 3 months post-completion of radiation
Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26
Time frame: Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
Change in quality of life as measured by FACT-En
Time frame: Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
Locoregional control
Time frame: Up to 12 months post-completion of radiation
Distant control
Time frame: Up to 12 months post-completion of radiation
Disease-free survival
Time frame: Up to 12 months post-completion of radiation
Overall survival
Time frame: Up to 12 months post-completion of radiation
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 20 Oct 2025.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) for individual participant data meta-analysis by investigators whose proposed use of data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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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.
Jessika Contreras, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity modulated radiation therapy in people with Endometrial Cancer, run by Washington University School of Medicine at 1 site in United States.
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 10 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: finished, as of the sponsor's last update on 20 Oct 2025. 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 United States. 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?
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?
Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events (time frame: From start of radiation through Day 90). The study lists 2 primary outcomes in all. 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 20 Oct 2025.