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Quality-of-Life Assessment for Pelvic Inflammatory Disease

Mayo Clinic in Arizona, Scottsdale, AZ
Pelvic Inflammatory Disease+3 More ConditionsQuality-of-Life Assessment - Other
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Pelvic Inflammatory Disease
  • Cervical Cancer
  • Endometrial Cancer
  • Endometriosis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

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Intensity-Modulated Radiation Therapy

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 3 years post-RT

Year 3
Change in overall patient quality of life
Year 3
Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
Week 5
Change in EPIC Urinary score
Year 3
Bowel and bladder dose-volume histogram (DVH) parameters
Incidence of grade 2+ hematologic toxicities
Overall survival (OS)
Progression-free survival
Well-being

Trial Safety

Phase-Based Safety

1 of 3

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1
Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
1
Intensity-Modulated Radiation Therapy
1
Intensity-Modulated Radiation Therapy

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Treatment (radiation therapy, questionnaires)
1 of 1

Experimental Treatment

120 Total Participants · 1 Treatment Group

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase < 1

Treatment (radiation therapy, questionnaires)Experimental Group · 3 Interventions: Quality-of-Life Assessment, Questionnaire Administration, Radiation Therapy · Intervention Types: Other, Other, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7360

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years post-rt

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,007 Previous Clinical Trials
3,513,098 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,279 Previous Clinical Trials
41,234,738 Total Patients Enrolled
Ivy A PetersenPrincipal InvestigatorMayo Clinic in Rochester

Eligibility Criteria

Age 18+ · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of smoking or pelvic infections, including pelvic inflammatory disease and endometriosis.
You are willing to answer questions about your quality of life during the study.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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