Whole Pelvis Proton Radiation for Gynecologic Cancer

Study Overview
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Brief Summary
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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
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Study Population: 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. Description of Sites/Facilities: The study will be conducted at the University of Pennsylvania Department of Radiation Oncology and associated Clinical facilities. Enrolling Sites: Enrolling sites are within the Penn institution and have proton capabilities. They include the following facilities: Penn Medicine Abramson Center in Philadelphia, PA Penn Medicine Lancaster General Health in Lancaster, PA Penn Medicine Virtua Voorhees in South New Jersey Description of Study Intervention: Patients will be treated with PBS PRT with doses of 45 or 50.4Gy relative biological effectiveness (RBE) in 1.8Gy daily fractions. Study Duration: The duration of the study will be 6 months after the last patient was treated. The recruitment period is planned over 24 months. Thus, estimated time from when study opens to completion of data analysis is 36 months. Participant Duration: 6 months from end of treatment, which including treatment time is approximately 7.5 months

Official Title
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Phase II Study of Whole Pelvis Proton Radiotherapy for Postoperative Gynecologic Cancer

Conditions
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Cervical Cancer, Uterine Cancer

Intervention / Treatment
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* Radiation: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Prior course of pelvic radiation Metastatic disease outside of the pelvis Active inflammatory bowel disease Incapacity to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | This will be assessed and documented up to 6 months after end of treatment at follow up visits. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute clinician-reported genitourinary (GU) toxicity. | Determine the rate of the acute patient-reported gastrointestinal (GI) and genitourinary (GU), with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria. | These surveys will be administered 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. | 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. | These surveys will be administered up to 6 months after end of treatment at follow up visits. | 
| Loco-regional recurrence free survival, disease free survival, and overall survival. | Determine loco-regional recurrence free survival, disease free survival, and overall survival. | The survival data will be followed until up to 2 years. |