PROton Therapy for Post Surgical Treatment of GYNecologic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT).
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Uterine Cancer, Endometrial Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers
Overview
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.
Interventions
- Radiation 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.
Primary outcome measures
- Acute clinician-reported gastrointestinal (GI) toxicity. [Time frame: Up to 6 months after end of treatment at follow up visits]
Secondary outcome measures (3)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Virtua Health — Voorhees Township
- Lancaster General Health - Ann B. Barshinger Cancer Institute — Lancaster
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT05758688 · UPCC 27822 · 852760