Recruiting
Early Phase 1

Radiation Therapy with Chemotherapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05691010

Conditions

Endometrial Cancer

Stage III Endometrial Cancer

Stage III Endometrial Carcinoma

Endometrial Carcinoma

Endometrial Carcinoma Stage III

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intensity-modulated radiation therapy

Carboplatin

Paclitaxel

Study Details

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.

Conditions

Endometrial Cancer

Stage III Endometrial Cancer

Stage III Endometrial Carcinoma

Endometrial Carcinoma

Endometrial Carcinoma Stage III

Study ID

NCT05691010

Start date

Jan 10, 2023

Status verified date

Jun, 2026

Completion date

Jan 10, 2027

Anticipated

Primary completion date

Jan 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Endometrial Cancer

Participants have stage III endometrial cancer

Interventions

Intensity-modulated radiation therapy

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

Carboplatin

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

Paclitaxel

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

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 ]

Central Contacts and Locations

Central contacts

Kaled Alektiar, MD

212-639-7981alektiak@mskcc.org

Vicky Makker, MD

646-888-4224makkerv@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Kalad Alektiar, MD

212-639-7981

Memorial Sloan Kettering Monmouth (All protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Kaled Alektiar, MD

212-639-7981

Memorial Sloan Kettering Bergen (All protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Kaled Alektiar, MD, MSc

212-639-7981

Memorial Sloan Kettering Commack (All protocol activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Kaled Alektiar, MD

212-639-7981

Memorial Sloan Kettering Westchester (All protocol activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Kaled Alektiar, MD

212-639-7981

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Kaled Alektiar, MD

212-639-7981

Samuel Singer, MD

212-639-2164

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Kaled Alektiar, MD

212-639-7981

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-25.