A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer

NCT ID: NCT05691010

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2026-01-10

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with Endometrial Cancer

Participants have stage III endometrial cancer

Group Type: EXPERIMENTAL

Intensity-modulated radiation therapy

Intervention Type: RADIATION

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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

Intervention Type: RADIATION

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

IMRT

Eligibility Criteria

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 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaled Alektair, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Commack (All protocol activities)

Commack, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kaled Alektiar, MD

Role: CONTACT

alektiak@mskcc.org

212-639-7981

Vicky Makker, MD

Role: CONTACT

makkerv@mskcc.org

646-888-4224

Facility Contacts

Kalad Alektiar, MD

Role: primary

212-639-7981

Kaled Alektiar, MD

Role: primary

212-639-7981

Kaled Alektiar, MD, MSc

Role: primary

212-639-7981

Kaled Alektiar, MD

Role: primary

212-639-7981

Kaled Alektiar, MD

Role: primary

212-639-7981

Kaled Alektiar, MD

Role: primary

212-639-7981

Samuel Singer, MD

Role: backup

212-639-2164

Kaled Alektiar, MD

Role: primary

212-639-7981

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

22-405

Identifier Type: -

Identifier Source: org_study_id