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Tailored Therapy for Endometrial Cancer

Phase 2
Recruiting
Led By Matthew Powell
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed
Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from enrollment to the time of radiological and/or histologic confirmation of para-aortic recurrence (i.e. nodal recurrence at/above l5/s1 and below the renal hilum), whichever occurs first, assessed up to 2 years
Awards & highlights

Summary

This trial is testing a new way to treat low-risk endometrial cancer after surgery. Instead of just surgery, doctors will analyze the tissue removed during surgery to decide if additional treatments like radiation or chemotherapy

Who is the study for?
This trial is for adults over 18 with stage I to III endometrial carcinoma who've had surgery with no remaining visible disease. They must be able to complete questionnaires in English, French or another validated language and live close enough to the treatment center for follow-up. Those unwilling to fill out questionnaires or unable to return for follow-ups are excluded.
What is being tested?
The study tests tailored therapy post-surgery in low-risk endometrial cancer patients. It involves analyzing surgically removed tissue to decide if additional treatments like radiation or chemotherapy are needed after surgery.
What are the potential side effects?
Potential side effects may include those typically associated with radiation therapy such as fatigue, skin irritation, and gastrointestinal discomfort; however, specific side effects will depend on individualized treatment plans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My endometrial cancer is confirmed and is stage I to III.
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I can care for myself and am up and about more than 50% of my waking hours.
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I am 18 years old or older.
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I had a hysterectomy and both ovaries removed with no visible cancer left.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from enrollment to the time of radiological and/or histologic confirmation of para-aortic recurrence (i.e. nodal recurrence at/above l5/s1 and below the renal hilum), whichever occurs first, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from enrollment to the time of radiological and/or histologic confirmation of para-aortic recurrence (i.e. nodal recurrence at/above l5/s1 and below the renal hilum), whichever occurs first, assessed up to 2 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
Decisional conflict
Fear of recurrence
Health economics
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Cohort A2Experimental Treatment8 Interventions
Patients with higher-risk POLE-mutated EC undergo observation or EBRT and/or vaginal brachytherapy over 3-5 fractions. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.
Group II: Sub-study BActive Control7 Interventions
Patients with p53 wildtype/NSMP ER+ EC undergo observation or vaginal brachytherapy over 3-5 fractions. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.
Group III: Cohort A1Active Control6 Interventions
Patients with POLE-mutated early-stage EC undergo observation on study. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2740
External Beam Radiation Therapy
2006
Completed Phase 3
~3300
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupNETWORK
127 Previous Clinical Trials
67,949 Total Patients Enrolled
NRG OncologyLead Sponsor
236 Previous Clinical Trials
101,950 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,675 Total Patients Enrolled
~217 spots leftby Jan 2027
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