PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

NCT05758688 | Recruiting Phase 2 FDA Device

• 2 other identifiers: UPCC 27822852760
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cervical Cancer; Uterine Cancer; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 months after end of treatment at follow up visits

Secondary Outcomes (3)

• Acute clinician-reported genitourinary (GU) toxicity.

  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.

  Up to 6 months after end of treatment at follow up visits

• Loco-regional recurrence free survival, disease free survival, and overall survival.

  Up to 2 years

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (3)

Virtua Health

Voorhees Township, New Jersey, 08043, United States

RECRUITING

Lancaster General Health - Ann B. Barshinger Cancer Institute

Lancaster, Pennsylvania, 17601, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Neil K Taunk, MD, MSCTS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

215-662-3790; RadOncCRU@PennMedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: March 7, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

US (3)