Cervical Cancer, Endometrial Cancer, Uterine Cancer
Conditions
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.
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
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.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute clinician-reported gastrointestinal (GI) toxicity. | Up to 6 months after end of treatment at follow up visits | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute clinician-reported genitourinary (GU) toxicity. | Up to 6 months after end of treatment at follow up visits | Determine the rate of the acute clinician-reported genitourinary (GU) toxicity, with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria. |
| 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 | Determine the rate of acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life using the EPIC urinary and bowel score (expanded prostate cancer index composite) and FACT-Cx. |
| Loco-regional recurrence free survival, disease free survival, and overall survival. | Up to 2 years | Determine loco-regional recurrence free survival, disease free survival, and overall survival. |
Countries
United States
Contacts
CONTACTProject Manager
PRINCIPAL_INVESTIGATORNeil K Taunk, MD, MSCTS
University of Pennsylvania
Outcome results
None listed