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Intensity Modulated Radiation Therapy

Proton vs IMRT After Surgery for Endometrial or Cervical Cancer

N/A

Recruiting

Led By Ivy A Petersen

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Histologically confirmed diagnosis of cervical or endometrial cancer

Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at an Institutional Review Board (IRB)-approved Mayo Clinic site

Must not have

Positive or close surgical margins (=< 3 mm)

Receiving external beam boost dose during RT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years post-rt

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the side effects of proton radiation therapy to intensity modulated radiation therapy for endometrial or cervical cancer patients.

Who is the study for?

This trial is for individuals with confirmed cervical or endometrial cancer who've had surgery. They should be in decent physical condition, not have severe infections or bowel disease, and must not have received pelvic radiation before. Participants need to agree to quality of life questionnaires and use a rectal balloon during radiation therapy.

What is being tested?

The study compares two types of post-surgery radiation treatments for endometrial or cervical cancer: proton radiation therapy versus intensity modulated radiation therapy (IMRT). It aims to see which causes fewer gastrointestinal side effects by using patient questionnaires and monitoring adverse events.

What are the potential side effects?

Potential side effects include gastrointestinal issues like upset stomach, diarrhea, fatigue from the treatment itself, skin reactions at the site of radiation, and possible inflammation in nearby organs due to high energy exposure.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with cervical or endometrial cancer.

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I am scheduled for proton or IMRT radiation with a rectal balloon at an approved Mayo Clinic site.

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I can take care of myself and am up and about more than half of the day.

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I am scheduled for radiation therapy to my pelvis, possibly including the area around my aorta.

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I had surgery to remove my uterus due to cervical or endometrial cancer.

Exclusion Criteria

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

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My surgery showed cancer cells close to the edge of the removed tissue.

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I am getting an extra dose of radiation during my treatment.

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My cancer is one of the following types: endometrial stromal sarcoma, leiomyosarcoma, melanoma, or small cell carcinoma.

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I haven't had serious heart issues or infections needing hospital care recently.

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I have visible tumors at the time of radiation therapy.

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I have had radiation therapy to my pelvic area before.

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I am scheduled for radiation therapy on my groin lymph nodes.

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I am unwilling to use a rectal balloon daily during radiation therapy.

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My cancer has spread to distant parts of my body.

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I have AIDS as defined by the CDC.

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I have liver problems causing jaundice or blood clotting issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years post-rt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years post-rt

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years post-rt 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 Expanded Prostate Cancer Index Composite (EPIC) Bowel score

Secondary study objectives

Bowel and bladder dose-volume histogram (DVH) parameters

Change in EPIC Urinary score

Change in overall patient quality of life

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (radiation therapy, questionnaires)Experimental Treatment3 Interventions

Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 16Eligibility criteria met