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New treatment option for Endometrial Cancer
Official title A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer
ClinicalTrials.gov ID: NCT05691010
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients must have newly diagnosed endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serous, clear...
- Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node surgical assessment (sentinel lymph node mapping...
- 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.
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
- Patients must have newly diagnosed endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serous, clear cell, dedifferentiated/undifferentiated, mixed epithelial...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.