ClinicalTrials.gg
RecruitingNCT05758688PROPS GYNUpdated Sep 17, 2026

PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

A Phase 2 interventional study of Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in Cervical Cancer, Uterine Cancer and Endometrial Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Abramson Cancer Center at Penn Medicine · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Uterine Cervical Neoplasms by Abramson Cancer Center at Penn Medicine — 2 open to participants now, 2 under way, none of them phase 3. Uterine Cervical Neoplasms · Abramson Cancer Center at Penn Medicine.

Started
2023
with 1 other
Phase 2
2 of 10
1 open now
Registered
8th of 10
by date

Among the 10 studies in Uterine Cervical Neoplasms by Abramson Cancer Center at Penn Medicine, this one is one of 2 that started in 2023, is one of 2 in phase 2, and was the 8th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

No phase4 · 1 open
Observational2 · 0 open
Phase 12 · 0 open
Phase 2this study2 · 1 open

By the year they started

First in 2003; this study’s year is marked. 2 started in 2023.

What they test

Size and results

Median enrollment 15 across the 7 interventional studies, 203 across the 2 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in Uterine Cervical Neoplasms by Abramson Cancer Center at Penn Medicine, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Cervical Cancer
  • Uterine Cancer
  • Endometrial Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed cervical or endometrial cancer
  • Indication for whole pelvic radiation therapy, with or without systemic therapy
  • Age of 18 years or older
  • Written
  • of 0-2 within 3 months of enrolling

Exclusion criteria

Exclusion Criteria:

  • Prior course of pelvic radiation
  • disease outside of the pelvis
  • Active inflammatory bowel disease
  • Incapacity to provide
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study 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.

    Radiation: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)

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.

06

What researchers measure

Primary outcomes

  1. 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. Acute GI grade 2 or higher toxicity is the primary powering endpoint.

    Time frame: Up to 6 months after end of treatment at follow up visits

Secondary outcomes

  1. Acute clinician-reported genitourinary (GU) toxicity.

    Determine the rate of the acute clinician-reported genitourinary (GU) toxicity, with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria.

    Time frame: Up to 6 months after end of treatment at follow up visits

  2. 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.

    Time frame: Up to 6 months after end of treatment at follow up visits

  3. Loco-regional recurrence free survival, disease free survival, and overall survival.

    Determine loco-regional recurrence free survival, disease free survival, and overall survival.

    Time frame: Up to 2 years

07

Study locations

3 of 3 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Nov 2026, 36 months after the start.

Of 154 non-industry phase 2 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 99. This study's planned 36 months is below that.

Counting every sponsor, half of 204 studies reached it within 42 months; a quarter within 29 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2023
First posted
Mar 7, 2023
StartActual
Nov 6, 2023
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05758688
Responsible party
Sponsor
First posted
Mar 7, 2023
Start date
Nov 6, 2023
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 17, 2026

Study contacts

Project Manager
Contact
RadOncCRU@PennMedicine.upenn.edu
215-662-3790
Neil K Taunk, MD, MSCTS
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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