PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

Part of paid clinical trials in Voorhees Township, New Jersey.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05758688
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Nov 6, 2023
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adjuvant 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 Measure

Acute clinician-reported gastrointestinal (GI) toxicity. [ Time Frame: Up to 6 months after end of treatment at follow up visits ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Virtua HealthVoorhees TownshipNew Jersey08043
Kristina Montagno, RN, BSN
[email protected]
856-206-4728
Barbara Dillon, MSN, RN
[email protected]
856-247-7395
Graeme Williams, MD, MBA (PRINCIPAL_INVESTIGATOR)
Lancaster General Health - Ann B. Barshinger Cancer InstituteLancasterPennsylvania17601
Susan Tollett, BSN, RN, OCN
[email protected]
717-544-0511
Alyson Eckert, BSN, RN, OCN
[email protected]
717-544-0511
Pamela Boimel, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Project Manager
[email protected]
MD
Neil K Taunk, MD, MSCTS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Voorhees Township, NJ

By condition
Cervical cancerEndometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Virtua Health· Voorhees Township, NJLancaster General Health - Ann B. Barshinger Cancer Institute· Lancaster, PAUniversity of Pennsylvania· Philadelphia, PA

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