A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer
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
1 other identifier
interventional
28
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jan 2023
Longer than P75 for early_phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2023
CompletedStudy Start
First participant enrolled
January 10, 2023
CompletedFirst Posted
Study publicly available on registry
January 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 10, 2027
February 4, 2026
February 1, 2026
4 years
January 10, 2023
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 3 years
Study Arms (1)
Participants with Endometrial Cancer
EXPERIMENTALParticipants have stage III endometrial cancer
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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 no more than 14 days 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
- +4 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaled Alektair, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2023
First Posted
January 19, 2023
Study Start
January 10, 2023
Primary Completion (Estimated)
January 10, 2027
Study Completion (Estimated)
January 10, 2027
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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.