RecruitingPhase 2NCT05758688

PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers

Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

25 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer Endometrial Cancer Uterine Cancer

Summary

This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying proton therapy — a more precise form of radiation — as an after-surgery treatment for women with cervical or endometrial (uterine) cancer. The hope is that proton therapy can target the pelvis more accurately and reduce side effects compared to standard radiation. **You may be eligible if...** - You have been diagnosed with cervical or endometrial cancer confirmed by biopsy - Your doctor recommends radiation therapy after surgery (called adjuvant pelvic radiation) - You are 18 years or older - You are generally well enough to participate (ECOG score 0–2) **You may NOT be eligible if...** - You have previously had pelvic radiation therapy - Your cancer has spread outside the pelvis - You have active inflammatory bowel disease - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONWhole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)

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.