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Proton Beam Therapy

Proton Radiation for Uterine Cancer (PROPS GYN Trial)

Phase 2

Recruiting

Led By Neil K Taunk, MD, MSCTS

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Histologically confirmed cervical or endometrial cancer

Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is a study being conducted at multiple hospitals to test the use of a specific type of radiation therapy called Whole Pelvis Pencil Beam Scanning Proton Radiation in women who have had surgery for

Who is the study for?

This trial is for adults over 18 with confirmed cervical or endometrial cancer who need additional radiation therapy after surgery. Participants should be able to perform daily activities with minimal assistance (ECOG 0-2) and must provide written consent.

What is being tested?

The study is testing a type of targeted radiation called Whole Pelvis Pencil Beam Scanning Proton Radiation in patients who have had surgery for gynecologic cancers, aiming to reduce gastrointestinal side effects.

What are the potential side effects?

Potential side effects may include acute gastrointestinal issues such as nausea, vomiting, diarrhea, and abdominal pain due to the radiation targeting the pelvic area.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed to be either cervical or endometrial.

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I am recommended to have radiation therapy for my pelvic area, with or without additional treatments.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Acute clinician-reported gastrointestinal (GI) toxicity.

Secondary study objectives

Acute clinician-reported genitourinary (GU) toxicity.

Acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life.

Loco-regional recurrence free survival, disease free survival, and overall survival.

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: Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)Experimental Treatment1 Intervention

The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions. The volume treated will include the whole pelvis according to Radiation Therapy Oncology Group post-hysterectomy pelvis guidelines.

0 / 4Eligibility criteria met