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Intensity Modulated Radiation Therapy

Proton vs IMRT After Surgery for Endometrial or Cervical Cancer

N/A

Recruiting

Led By Allison E. Garda, M.D.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years post-rt

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score

Secondary outcome measures

Bowel and bladder dose-volume histogram (DVH) parameters

Change in EPIC Urinary score

Change in overall patient quality of life

+4 more

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,208 Previous Clinical Trials

3,766,930 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,953 Total Patients Enrolled

Allison E. Garda, M.D.Principal InvestigatorMayo Clinic in Rochester

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Intensity Modulated Radiation Therapy (Intensity Modulated Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04567771 — N/A

Pelvic Inflammatory Disease Research Study Groups: Treatment (radiation therapy, questionnaires)

Pelvic Inflammatory Disease Clinical Trial 2023: Intensity Modulated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04567771 — N/A

Intensity Modulated Radiation Therapy (Intensity Modulated Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04567771 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this experiment at present?

"As per records published on clinicaltrials.gov, this medical investigation is in need of enrollees. It was first announced on December 4th 2020 and has been amended most recently on June 16th 2022."

Answered by AI

How many participants are actively engaged in this experiment?

"Affirmative. Clinicaltrials.gov conveys that this medical trial, which was initially advertised on December 4th 2020, is actively recruiting participants. This study seeks to enroll 120 individuals from 3 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

2020. "Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04567771.

All > Cervical Cancer > Endometriosis