← Back to Search

Radiation

Hypofractionated Radiotherapy for Endometrial Cancer

Phase 1 & 2

Recruiting

Led By Christina Son, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Diagnosis of endometrial cancer with any of the following primary histologic types: endometrioid, papillary serous, clear cell, carcinosarcoma, or mixed epithelial histologies

Age ≥ 18 years

Must not have

History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis

Concurrent (or other) chemotherapy occurring at the time of study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a shorter, more intense course of radiation is safe and effective for treating endometrial cancer.

Who is the study for?

This trial is for women over 18 with Stage I-III endometrial cancer who've had a hysterectomy and show no signs of remaining cancer or distant metastases. It's not for those receiving concurrent chemotherapy, with bowel issues, prior pelvic radiation, unresolved chemo side effects, or connective tissue disorders.

What is being tested?

The study tests if a shorter course of higher-dose pelvic radiation (hypofractionation) is safe and effective in treating endometrial cancer compared to the standard longer treatment. The goal is to find the best dose that's both tolerable and similar in effectiveness to conventional therapy.

What are the potential side effects?

Potential side effects may include skin irritation at the treatment site, fatigue, digestive problems like diarrhea or nausea due to increased daily doses of radiation even though overall treatment time is reduced.

Eligibility Criteria

Inclusion Criteria

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

Select...

My diagnosis is endometrial cancer with a specific cell type.

Select...

I am 18 years old or older.

Select...

My cancer was diagnosed as Stage I-III by FIGO standards.

Select...

I had surgery to remove my uterus without any visible cancer left and may or may not have had my lymph nodes checked.

Exclusion Criteria

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

Select...

I have a history of bowel issues or connective tissue disorder needing ongoing treatment, or I've had pelvic radiation.

Select...

I am not currently undergoing any chemotherapy.

Select...

I have ongoing diarrhea or stomach pain from chemotherapy that needs medication.

Select...

My endometrial cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in patient-reported acute gastrointestinal side effects after completion of hypofractionated radiation (Phase 2)

The Maximum Tolerated Dose of Hypofractionated Whole Pelvic Radiation Treatment (Phase 1)

Secondary study objectives

Change in gastrointestinal toxicity over time

Change in patient-reported acute urinary side effects

Financial Distress of Treatment

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Hypofractionated Radiation Treatment (Dose-Finding Arm)Experimental Treatment1 Intervention

All study participants in this arm will receive hypofractionated whole pelvic radiation treatment for a shortened time period of 3-5 weeks. The goal of this arm is to establish a safe and tolerable dose of shortened (hypofractionated) pelvic radiation treatment for study participants. Once a safe and tolerable dose is established for this shortened form of radiation treatment, participants who meet criteria for the second phase of this study will participate in an expansion cohort that will explore the efficacy (how effective shortened/hypofractionated radiation treatment is for treating endometrial cancer).

Group II: Expansion Cohort (Efficacy Arm)Experimental Treatment1 Intervention

Participants in this arm will test how effective hypofractionated/shortened whole radiation treatment is ("efficacy") at the dose established in the first phase of this study by following up with their doctors to report their current health status and symptoms during clinical visits. Participants will return for routine clinical follow-up approximately 1 month following radiation, then at 3 months following radiation, then every 3 months for the next 2 years following treatment.

0 / 8Eligibility criteria met