Endometrial CancerEarly Phase 1NCT05691010
A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer
A Early Phase 1 study testing Intensity-modulated radiation therapy, Carboplatin and Paclitaxel in people with Endometrial Cancer and Stage III Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to find out whether short-course radiation therapy (1 week instead of the usual 5 weeks) with chemotherapy (carboplatin and paclitaxel) is practical (feasible), meaning that most participants are able to complete the treatment schedule. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Stage III Endometrial Cancer, Stage III Endometrial Carcinoma
- What is being tested?
- Intensity-modulated radiation therapy, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Jan 2023to 10 Jan 2027
- Phase
- Early Phase 1
- 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
- Patients must have newly diagnosed endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serous, clear cell, dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma not otherwise specified, and carcinosarcoma.
- Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node surgical assessment (sentinel lymph node mapping and/or sampling). Para-aortic lymph node surgical assessment is optional.
- Patients must have FIGO (2009) stage IIIA or IIIC1 disease (as determined by surgical staging).
- Patients must consent to testing with MSK-IMPACT part A and are encouraged to consent to both parts A and C.
- Age ≥ 18 years.
- Patients must have an Karnofsky Performance Status (KPS) ≥ 70 (or ECOG 0 or 1).
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- Neurologic function: Neuropathy (sensory and motor) grade ≤ 1.
- No residual gross disease after surgery.
- No prior radiation therapy or chemotherapy for treatment of endometrial cancer.
- No active infection requiring antibiotics, except for uncomplicated urinary tract infection.
- Patients must have adequate organ function, defined by the following laboratory results prior to first study treatment:
- Absolute neutrophil count (ANC) ≥ 1500/mcL
- Platelet count ≥ 100,000/mcL
- AST/ALT ≤ 3X upper limit of normal (ULN)
- Total bilirubin ≤ 1.5X ULN. Patients with known Gilbert's disease and a total bilirubin ≤ 3X ULN may be enrolled.
- Creatinine ≤ 1.5X ULN
- Entry into study is limited to no more than 12 weeks from the date of surgery.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patients of childbearing age will by definition have undergone hysterectomy and bilateral oophorectomy prior to study enrollment.
- Participants must agree not to breastfeed during the study or for 150 days after the last dose of study treatment.
Who cannot join
- Patients whose endometrial cancers harbor known pathogenic POLE mutations
- Patients whose endometrial cancers are mismatch repair deficient, as determined by immunohistochemical staining for MLH1, PMS2, MSH2, and MSH6 and/or MSI-H
- Active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. This includes but is not limited to: uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, and superior vena cava syndrome.
- Patients unfit for pelvic radiation therapy due to the following:
- Has had radiation therapy encompassing >20% of the bone marrow within 2 weeks, or any radiation therapy within 1 week prior to day 1 of protocol therapy
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- Patients with a history of pelvic radiation.
- Patients with a history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.
- Any hematological abnormality or disorder that would be a contraindication to radiation per the treating physician.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920
Kalad Alektiar, MD, 212-639-7981
- Recruiting
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, 11725
Kaled Alektiar, MD, 212-639-7981
- Recruiting
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Kaled Alektiar, MD, 212-639-7981
- Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Kaled Alektiar, MD, 212-639-7981
- Recruiting
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Kaled Alektiar, MD, MSc, 212-639-7981
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Kaled Alektiar, MD, 212-639-7981
Samuel Singer, MD, 212-639-2164
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, 11553
Kaled Alektiar, MD, 212-639-7981
About this study
Official title: A Feasibility Study of Integrated Delivery of Hypofractionated Pelvic IMRT With Carboplatin and Paclitaxel in Stage III Copy-Number Low and Copy-Number High Subtypes of Endometrial Cancer
The purpose of this study is to find out whether short-course radiation therapy (1 week instead of the usual 5 weeks) with chemotherapy (carboplatin and paclitaxel) is practical (feasible), meaning that most participants are able to complete the treatment schedule.
- Conditions
- Endometrial Cancer, Stage III Endometrial Cancer, Stage III Endometrial Carcinoma, Endometrial Carcinoma, Endometrial Carcinoma Stage III
- Being tested
- Intensity-modulated radiation therapy, Carboplatin, Paclitaxel
- Keywords
- endometrial cancer, endometrial cancer stage III, endometrial carcinoma stage III, stage III endometrial cancer, stage III endometrial carcinoma, Memorial Sloan Kettering Cancer Center, 22-405
- 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
After cycles 1, 2, 3 or 4 of chemotherapy, patients will receive IMRT to the vaginal cuff and pelvic lymph nodes with a total dose of 25 Gy delivered in 5 daily fractions of 5 Gy
CarboplatinDrug
Patients enrolled in this trial will receive chemotherapy with carboplatin IV AUC 5 at the discretion of the treating investigator plus paclitaxel 175 mg/m2 every 21 days for 6 cycles
PaclitaxelDrug
Patients enrolled in this trial will receive chemotherapy with carboplatin IV AUC 5 at the discretion of the treating investigator plus paclitaxel 175 mg/m2 every 21 days for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Participants with Endometrial Cancer | Experimental | Participants have stage III endometrial cancer Receives: Radiation: Intensity-modulated radiation therapy; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of integrated delivery of short-course IMRT with carboplatin/paclitaxel in patients with stage III endometrial cancer
Feasibility of study treatment is defined as defined as the number of participants who complete all 6 planned cycles of carboplatin and paclitaxel with no delays in chemotherapy cycles greater than 21 days.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start10 Jan 2023
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Jan 2027 (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 Memorial Sloan Kettering Cancer 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaled Alektair, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691010
- Sponsor's protocol ID
- 22-405
- Status last verified
- Jun 2026
- First submitted
- 10 Jan 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Integrated Delivery of Hypofractionated Pelvic IMRT With Carboplatin and Paclitaxel in Stage III Copy-Number Low and Copy-Number High Subtypes of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05691010
- Acronym / sponsor ID
- 22-405
- Conditions
- Endometrial Cancer, Stage III Endometrial Cancer, Stage III Endometrial Carcinoma, Endometrial Carcinoma, Endometrial Carcinoma Stage III
- Keywords
- endometrial cancer, endometrial cancer stage III, endometrial carcinoma stage III, stage III endometrial cancer, stage III endometrial carcinoma, Memorial Sloan Kettering Cancer Center, 22-405
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 19 Jan 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.
The purpose of this study is to find out whether short-course radiation therapy (1 week instead of the usual 5 weeks) with chemotherapy (carboplatin and paclitaxel) is practical (feasible), meaning that most participants are able to complete the treatment schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Endometrial Cancer | Experimental | Radiation: Intensity-modulated radiation therapy, Drug: Carboplatin, Drug: PaclitaxelParticipants have stage III endometrial cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients must have newly diagnosed endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serous, clear cell, dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma not otherwise specified, and carcinosarcoma.
- Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node surgical assessment (sentinel lymph node mapping and/or sampling). Para-aortic lymph node surgical assessment is optional.
- Patients must have FIGO (2009) stage IIIA or IIIC1 disease (as determined by surgical staging).
- Patients must consent to testing with MSK-IMPACT part A and are encouraged to consent to both parts A and C.
- Age ≥ 18 years.
Key exclusion criteria (9 listed)
- Patients whose endometrial cancers harbor known pathogenic POLE mutations
- Patients whose endometrial cancers are mismatch repair deficient, as determined by immunohistochemical staining for MLH1, PMS2, MSH2, and MSH6 and/or MSI-H
- Active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. This includes but is not limited to: uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, and superior vena cava syndrome.
- Patients unfit for pelvic radiation therapy due to the following:
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: IMRTAfter cycles 1, 2, 3 or 4 of chemotherapy, patients will receive IMRT to the vaginal cuff and pelvic lymph nodes with a total dose of 25 Gy delivered in 5 daily fractions of 5 Gy | Radiation | Participants with Endometrial Cancer |
| CarboplatinPatients enrolled in this trial will receive chemotherapy with carboplatin IV AUC 5 at the discretion of the treating investigator plus paclitaxel 175 mg/m2 every 21 days for 6 cycles | Drug | Participants with Endometrial Cancer |
| PaclitaxelPatients enrolled in this trial will receive chemotherapy with carboplatin IV AUC 5 at the discretion of the treating investigator plus paclitaxel 175 mg/m2 every 21 days for 6 cycles | Drug | Participants with Endometrial Cancer |
Primary outcome
Feasibility of integrated delivery of short-course IMRT with carboplatin/paclitaxel in patients with stage III endometrial cancer
Time frame: up to 3 years
Feasibility of study treatment is defined as defined as the number of participants who complete all 6 planned cycles of carboplatin and paclitaxel with no delays in chemotherapy cycles greater than 21 days.
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 25 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Kaled Alektair, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intensity-modulated radiation therapy, Carboplatin and Paclitaxel in people with Endometrial Cancer and Stage III Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 20 inclusion and 9 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kaled Alektiar, MD (212-639-7981, alektiak@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of integrated delivery of short-course IMRT with carboplatin/paclitaxel in patients with stage III endometrial cancer (time frame: up to 3 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 25 Jun 2026.