PROton Therapy for Post Surgical Treatment of GYNecologic Cancer (PROPS GYN)

Abramson Cancer Center at Penn Medicine

Status and phase: Enrolling; Phase 2

Conditions: Endometrial Cancer; Uterine Cancer; Cervical Cancer

Treatments: Radiation: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05758688

UPCC 27822

852760

Details and patient eligibility

About

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.

Full description

This is a single institution, multi-site study, and thus will include patients from geographic locations with Penn proton centers in the Philadelphia, Lancaster and South New Jersey area. The study will be conducted at the University of Pennsylvania Department of Radiation Oncology and associated Clinical facilities.

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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)

Experimental group

Description:

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.

Treatment:

Radiation: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)