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Hypofractionated Radiation Therapy for Endometrial Cancer

N/A

Recruiting

Led By Teresa Meier, MD

Research Sponsored by Teresa Meier

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years.

ECOG performance status ≤2 (Karnofsky ≥60%).

Must not have

Patients with an Inflammatory Bowel Disease diagnosis, regardless of disease activity.

Patients with current, active disease involving periaortic node(s). This is based on histologically positive para-aortic node(s) removed at time of surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a lower dose of radiation therapy spread out over a longer period of time is as effective at treating endometrial cancer as the standard higher dose given in a shorter timeframe.

Who is the study for?

This trial is for adults over 18 with stage I, II, or III endometrial cancer who've had a hysterectomy and possibly lymph node removal. It's suitable for those needing pelvic radiation but not vaginal cuff brachytherapy due to anatomy or higher risk of nodal recurrence. Participants must be in good general health (ECOG ≤2) and able to consent.

What is being tested?

The study tests hypofractionated whole pelvis radiation therapy as an additional treatment after surgery for endometrial cancer patients. The goal is to see if this type of targeted radiation can effectively treat the area around where the tumor was located.

What are the potential side effects?

While specific side effects are not listed, generally, pelvic radiation can cause fatigue, skin irritation in treated areas, digestive issues like diarrhea or discomfort during bowel movements, bladder irritation leading to urinary urgency or pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I have had surgery to remove my uterus, both ovaries, and fallopian tubes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Inflammatory Bowel Disease.

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I have active disease in the nodes around my aorta confirmed by surgery.

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I have had pelvic radiotherapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose per fraction (MTDF) of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer through CTCAE data and gastrointestinal PRO-CTCAE data.

Safety profile of hypofractionated, isoeffective whole pelvis radiation regimens for post-operative treatment of endometrial cancer using CTCAE version 5.0 and Patient Reported Outcome-CTCAE.

Secondary study objectives

Impact of hypofractionated WPRT on patient quality of life using the Functional Assessment of Cancer Therapy-Endometrial version 4.0.

Patient compliance with hypofractionated WPRT, as defined by how many patients are able to complete WPRT without a break in treatment.