Actively Recruiting
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
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-04
28
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a shorter course of radiation therapy combined with chemotherapy is practical for people with stage III endometrial cancer. The study focuses on delivering radiation over 1 week instead of the usual 5 weeks, alongside chemotherapy drugs carboplatin and paclitaxel. This early-phase study aims to see if most participants can complete this treatment plan successfully. Participants receive chemotherapy with carboplatin and paclitaxel every 21 days for six cycles. After some chemotherapy cycles, intensity-modulated radiation therapy (IMRT) is delivered to the vaginal cuff and pelvic lymph nodes, totaling 25 Gy over 5 daily doses of 5 Gy each. Radiation is given after cycles 1, 2, 3, or 4 of chemotherapy. During the study, participants will be closely monitored for their ability to complete treatment and for any side effects. Researchers will assess the feasibility of this integrated treatment over up to three years. The study involves regular visits, laboratory tests, and clinical assessments to track participants' health and response to the combined therapies.
CONDITIONS
Brief Title
A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have newly diagnosed endometrial carcinoma of specified subtypes.
- Surgery must include hysterectomy, removal of ovaries and fallopian tubes, and pelvic lymph node assessment.
- Patients must have FIGO stage IIIA or IIIC1 disease.
- Patients must consent to MSK-IMPACT part A testing.
- Age 18 years or older.
- Karnofsky Performance Status of 70 or higher (or ECOG 0 or 1).
- Neuropathy grade 1 or less.
- No residual gross disease after surgery.
- No prior radiation or chemotherapy for endometrial cancer.
- No active infection requiring antibiotics except uncomplicated urinary tract infection.
- Adequate organ function based on specified lab results within 14 days before treatment.
- Enrollment within 12 weeks of surgery.
- Patients with prior or concurrent malignancy are eligible if it does not interfere with study.
- Patients of childbearing age must have had hysterectomy and bilateral oophorectomy.
- Must agree not to breastfeed during study and for 150 days after last treatment.
You will not qualify if you...
- Patients with endometrial cancers having known pathogenic POLE mutations.
- Patients with mismatch repair deficient endometrial cancers.
- Active inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
- Conditions or therapies that might interfere with participation or safety as judged by investigator.
- Unfit for pelvic radiation due to recent or prior extensive radiation therapy.
- History or current diagnosis of vesicovaginal, enterovaginal, or colovaginal fistula.
- Any blood disorder that contraindicates radiation therapy according to physician assessment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of chemotherapy plus concurrent radiation)
Participants receive chemotherapy with carboplatin and paclitaxel every 21 days for 6 cycles. After cycles 1, 2, 3, or 4 of chemotherapy, participants receive short-course radiation therapy (IMRT) to the vaginal cuff and pelvic lymph nodes with a total dose of 25 Gy delivered in 5 daily fractions.
6 chemotherapy visits every 3 weeks and 5 daily radiation visits during treatment
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
K
Kaled Alektiar, MD
V
Vicky Makker, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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