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

Inclusion Criteria5

Histologically confirmed cervical or endometrial cancer
Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy
Age of 18 years or older
Written informed consent
ECOG of 0-2 within 3 months of enrolling

Exclusion Criteria4

Prior course of pelvic radiation
Metastatic disease outside of the pelvis
Active inflammatory bowel disease
Incapacity to provide informed consent

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.