Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
New Jersey
Virtua Health
RECRUITING
Voorhees Township
Pennsylvania
Lancaster General Health - Ann B. Barshinger Cancer Institute
RECRUITING
Lancaster
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Project Manager
RadOncCRU@PennMedicine.upenn.edu
215-662-3790
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2026-11
Participants
Target number of participants: 25
Treatments
Experimental: Adjuvant Whole 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.
Related Therapeutic Areas
Sponsors
Leads: Abramson Cancer Center at Penn Medicine