Clinical trial NCT05758688: PROton Therapy for Post Surgical Treatment of GYNecologic Cancer
Official title: Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Uterine Cancer
Endometrial Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acute clinician-reported gastrointestinal (GI) toxicity.
timeFrame: Up to 6 months after end of treatment at follow up visits
Secondary outcomes:
measure: Acute clinician-reported genitourinary (GU) toxicity.
timeFrame: Up to 6 months after end of treatment at follow up visits
measure: Acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life.
timeFrame: Up to 6 months after end of treatment at follow up visits
measure: Loco-regional recurrence free survival, disease free survival, and overall survival.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Voorhees
country: United States
facility: Virtua Health
state: New Jersey
city: Lancaster
country: United States
facility: Lancaster General Health - Ann B. Barshinger Cancer Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Neil K Taunk, MD, MSCTS
role: PRINCIPAL_INVESTIGATOR
References: