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Alkylating agents

Radiation + Chemotherapy for Endometrial Cancer

Phase < 1
Recruiting
Led By Kaled Alektair, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No active infection requiring antibiotics, except for uncomplicated urinary tract infection.
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.
Must not have
Patients whose endometrial cancers are mismatch repair deficient, as determined by immunohistochemical staining for MLH1, PMS2, MSH2, and MSH6 and/or MSI-H by MSK-IMPACT testing.
Patients with a history of pelvic radiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at a shorter radiation treatment with chemo to see if it's practical and can be completed by most patients.

Who is the study for?
This trial is for adults with newly diagnosed endometrial carcinoma who've had specific surgeries and have no residual disease. They must not be breastfeeding, have good organ function, and a performance status indicating they can care for themselves. Excluded are those with certain genetic markers or prior treatments, active infections needing antibiotics (except simple UTIs), or conditions that could affect the trial's safety or results.
What is being tested?
The study tests if a shorter radiation therapy course (1 week) combined with chemotherapy drugs carboplatin and paclitaxel is feasible for patients to complete compared to the usual 5-week radiation schedule. It aims to see if participants can stick to this condensed treatment plan without significant issues.
What are the potential side effects?
Potential side effects include reactions from radiation like skin irritation and fatigue, as well as chemotherapy-related nausea, hair loss, nerve damage (neuropathy), blood cell count changes increasing infection risk, liver impact shown by altered lab tests, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on antibiotics for an infection, except for a simple UTI.
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I have been newly diagnosed with a specific type of endometrial cancer.
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My surgery removed all visible cancer.
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My nerve damage does not significantly affect my daily activities.
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I have not had any treatments for endometrial cancer.
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I am mostly able to care for myself and carry out daily activities.
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I am 18 years old or older.
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I have had surgery that included removal of the uterus, both ovaries, fallopian tubes, and a check of pelvic lymph nodes.
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My condition is in the advanced stage IIIA or IIIC1 according to FIGO 2009.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My endometrial cancer lacks certain proteins, confirmed by specific tests.
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I have had radiation treatment in my pelvic area.
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My endometrial cancer has a specific genetic change found through testing.
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I haven't had significant radiation therapy affecting my bone marrow in the last 2 weeks.
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I don't have any health issues that could affect my trial participation.
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My doctor says I can't have radiation due to a blood disorder.
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My endometrial cancer's molecular features are unknown due to testing issues.
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My radiation treatment plan didn't meet specific safety limits.
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I have an active inflammatory bowel condition like Crohn's or ulcerative colitis.
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I have or had a fistula connecting my bladder, intestine, or colon to my vagina.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of integrated delivery of short-course IMRT with carboplatin/paclitaxel in patients with stage III endometrial cancer

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Endometrial CancerExperimental Treatment3 Interventions
Participants have stage III endometrial cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5450
Carboplatin
2014
Completed Phase 3
~6120
Intensity-modulated radiation therapy
2006
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,815 Total Patients Enrolled
20 Trials studying Endometrial Cancer
5,107 Patients Enrolled for Endometrial Cancer
Kaled Alektair, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05691010 — Phase < 1
Endometrial Cancer Research Study Groups: Participants with Endometrial Cancer
Endometrial Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05691010 — Phase < 1
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05691010 — Phase < 1
~0 spots leftby Jan 2025
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