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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

No Placebo-Only Group

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 weeks3 visits

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2790