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NCT05691010 | RECRUITING | Endometrial Cancer

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

Memorial Sloan Kettering Cancer Center

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.

Condition or disease

Endometrial Cancer

Stage III Endometrial Cancer

Stage III Endometrial Carcinoma

Endometrial Carcinoma

Endometrial Carcinoma Stage III

Intervention/treatment

Intensity-modulated radiation therapy

Carboplatin

Paclitaxel

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 28 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-01-10
Estimated Primary Completion Date : 2026-01-10
Estimated Study Completion Date : 2026-01-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer

Location Details

NCT05691010

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Commack (All protocol activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, United States, 11553