A Study of Short-Course Radiation Therapy With Chemotherapy for Endometrial Cancer
This study is looking at a new way to treat Stage III endometrial cancer. It combines a shorter course of radiation therapy (one week instead of the usual five weeks) with chemotherapy drugs called carboplatin and paclitaxel. The main goal is to see if this shorter treatment plan is practical and if most participants can complete it. You may be able to join if you are a woman, 18 years or older, and have newly diagnosed endometrial cancer of certain types. The study aims to measure how well this treatment plan works over three years.
- Study design
- This is an interventional study with a planned enrollment of 28 participants. The phase of the study is not specified.
- What's involved
- Patients will receive chemotherapy with carboplatin and paclitaxel every 21 days for 6 cycles. After cycles 1, 2, 3, or 4 of chemotherapy, patients will receive radiation therapy for 5 daily fractions.
- Compensation
- Not stated in the trial record.
- Follow-up
- The feasibility of the treatment will be measured for up to 3 years.
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NCT05691010
A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer
Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~28 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Intensity-modulated radiation therapyCarboplatinPaclitaxel
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of integrated delivery of short-course IMRT with carboplatin/paclitaxel in patients with stage III endometrial cancer
Measured over up to 3 years
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Kaled Alektair, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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).
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.
Exclusion
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
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.
What this trial measures
- Feasibility of integrated delivery of short-course IMRT with carboplatin/paclitaxel in patients with stage III endometrial cancerup 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.