RECRUITING

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

Conditions

Endometrial Cancer Stage III Endometrial Cancer Stage III Endometrial Carcinoma Endometrial Carcinoma Endometrial Carcinoma Stage III endometrial cancer stage III Memorial Sloan Kettering Cancer Center 22-405

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-10

Study Completion:2025-01-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05691010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Kaled Alektiar, MD

CONTACT

212-639-7981

alektiak@mskcc.org

Vicky Makker, MD

CONTACT

646-888-4224

makkerv@mskcc.org

Principal Investigator

Kaled Alektair, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Kaled Alektair, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-10

Study Completion Date2025-01-10

Study Record Updates

Study Start Date2023-01-10

Study Completion Date2025-01-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Endometrial Cancer
Stage III Endometrial Cancer
Stage III Endometrial Carcinoma
Endometrial Carcinoma
Endometrial Carcinoma Stage III