Short-course radiation therapy with chemotherapy for endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility of a short-course radiation therapy regimen lasting one week, combined with chemotherapy using carboplatin and paclitaxel, for patients with newly diagnosed stage III endometrial carcinoma. The goal is to determine if most participants can complete the treatment schedule successfully. Eligible patients must have undergone specific surgical procedures and have no residual disease post-surgery. The study aims to streamline treatment while maintaining effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Memorial Sloan Kettering Basking Ridge (All protocol activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All protocol activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All protocol activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Commack (All protocol activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All protocol activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Kaled Alektair, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Kaled Alektiar, MD
• Email: alektiak@mskcc.org
• Phone: 212-639-7981

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Molecular and ctDNA profiling for high-risk endometrial cancer

  This project will collect blood and tumor tissue to test whether tumor DNA and other genetic changes can help predict recurrence in people with high-risk endometrial cancer.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07062016

• Combining Carboplatin, Paclitaxel, and Pembrolizumab for Advanced Endometrial Cancer

  This study is testing a new combination of drugs for people with advanced endometrial cancer to see if it helps them live longer without their cancer getting worse.

  Recruiting at 6 sites Phase 2 Yonsei University · Kyeonggi-do and 5 other locations · NCT06502743

• Combination of a HER2-targeting vaccine and immunotherapy for advanced endometrial cancer

  This study is testing a new combination treatment for advanced endometrial cancer that includes a personalized vaccine made from patients' own blood, along with other medications, to see if it helps those whose cancer has progressed after other treatments.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06253494

• Personalized navigation to support rural and Black women with endometrial cancer

  This pilot tests a tailored patient-navigation program to help rural and Black patients with endometrial cancer access care and services.

  Recruiting UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT07927244

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• Methylation markers in self-samples to help detect gynecological cancers

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.