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Trial Title:
PROton Therapy for Post Surgical Treatment of GYNecologic Cancer
NCT ID:
NCT05758688
Condition:
Cervical Cancer
Uterine Cancer
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Uterine Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
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.
Arm group label:
Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Project Manager
Email:
RadOncCRU@PennMedicine.upenn.edu
Contact backup:
Last name:
MD
Investigator:
Last name:
Neil K Taunk, MD, MSCTS
Email:
Principal Investigator
Start date:
November 6, 2023
Completion date:
November 2026
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05758688
