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Alkylating agents
Radiation Therapy for Endometrial Cancer
Phase 2
Waitlist Available
Led By Matthew Harkenrider, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status 0-2
Serous Carcinoma, Clear Cell Carcinoma, Carcinosarcoma Stage I-IIIC1, IVA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial will test if a combination of chemotherapy, radiation, and drugs is safe for endometrial cancer. If safe, it would be tested for efficacy in a Phase III study.
Who is the study for?
This trial is for individuals with high-risk endometrial cancer who've had surgery. It's open to those with certain types of cancer cells, recommended for combined chemo and radiotherapy post-surgery, without prior pelvic radiation or evidence of spread beyond the pelvis. Participants must be able to perform daily activities with little to no assistance (ECOG 0-2) and give informed consent.Check my eligibility
What is being tested?
The trial tests how safe it is to use Carboplatin and Paclitaxel chemotherapy in sequence or at the same time as external beam radiotherapy after surgery. The main focus is on severe side effects from this treatment combination. Initially, 11 patients will be tested; if too many experience serious side effects, the study may stop early.See study design
What are the potential side effects?
Potential serious side effects include significant non-blood related toxicities like organ damage (grade 3-4), and severe blood-related issues (grade 4). These could lead to stopping the treatment if they occur frequently among participants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself and am up and about more than 50% of my waking hours.
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My cancer is in stages I to IV and is one of the specified types.
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I have never had radiation therapy to my pelvic area.
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My doctor recommends both chemotherapy and radiation after reviewing my cancer.
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My cancer has not spread to lymph nodes or other parts of my body.
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I had surgery for endometrial cancer with a specific type of tumor.
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My endometrial cancer is at an early or specific advanced stage with high risk features.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Toxicities (CTCAE v5.0)
Secondary outcome measures
Chronic Toxicities (CTCAE v5.0)
Treatment Delays
cause-specific survival
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Full Dose Chemo, Reduced Dose Chemo + RT, Full Dose ChemoExperimental Treatment2 Interventions
Week 1 : Cycle 1: Full Dose Carboplatin and Paclitaxel Week 4: Pelvic Radiotherapy Begins Cycle 2: Dose reduced Carboplatin and Paclitaxel Week 7 : Cycle 3: Dose reduced Carboplatin and Paclitaxel Weeks 10,13,16: Cycle 4-6: Full Dose Carboplatin and Paclitaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,910 Total Patients Enrolled
Matthew Harkenrider, MDPrincipal Investigator - Loyola University Chicago
Loyola University Medical Center, Presence Resurrection Medical Center
Indiana University School Of Medicine (Medical School)
1 Previous Clinical Trials
41 Total Patients Enrolled
Frequently Asked Questions
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