Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers
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.
Detailed 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.
Arms & 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.
Outcome measures
Primary
Acute clinician-reported gastrointestinal (GI) toxicity.
Determine the rate of acute clinician-reported gastrointestinal (GI), with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria. Acute GI grade 2 or higher toxicity is the primary powering endpoint.
Time frame: Up to 6 months after end of treatment at follow up visits
Secondary
Acute clinician-reported genitourinary (GU) toxicity.
Time frame: Up to 6 months after end of treatment at follow up visits
Acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life.
Time frame: Up to 6 months after end of treatment at follow up visits
Loco-regional recurrence free survival, disease free survival, and overall survival.
Time frame: Up to 2 years
Eligibility criteria
Study locations (3)
Virtua Health
Voorhees Township, New Jersey, 08043
Lancaster General Health - Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601
University of Pennsylvania
Philadelphia, Pennsylvania, 19104