Cervical CancerPhase 2PROPS GYNNCT05758688
PROton Therapy for Post Surgical Treatment of GYNecologic Cancer
A Phase 2 study testing Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in people with Cervical Cancer and Uterine Cancer, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Uterine Cancer, Endometrial Cancer
- What is being tested?
- Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Nov 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior course of pelvic radiation
- Metastatic disease outside of the pelvis
- Active inflammatory bowel disease
- Incapacity to provide informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Lancaster General Health - Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601
Susan Tollett, BSN, RN, OCN, 717-544-0511, susan.tollett@pennmedicine.upenn.edu
Alyson Eckert, BSN, RN, OCN, 717-544-0511, alyson.eckert@pennmedicine.upenn.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Project Manager, RadOncCRU@PennMedicine.upenn.edu
MD
- Recruiting
Virtua Health
Voorhees Township, New Jersey, 08043
Kristina Montagno, RN, BSN, 856-206-4728, kmontag1@virtua.org
Barbara Dillon, MSN, RN, 856-247-7395 ext. 77395, bdillon@virtua.org
About this study
Official title: Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers
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.
- Conditions
- Cervical Cancer, Uterine Cancer, Endometrial Cancer
- Being tested
- Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) | Experimental | 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. Receives: Radiation: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months after end of treatment at follow up visits
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start6 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil K Taunk, MD, MSCTS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758688
- Sponsor's protocol ID
- UPCC 27822
- Other IDs
- 852760
- Acronym
- PROPS GYN
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers
- ClinicalTrials.gov ID
- NCT05758688
- Acronym / sponsor ID
- PROPS GYN / UPCC 27822
- Conditions
- Cervical Cancer, Uterine Cancer, Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) | Experimental | Radiation: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Prior course of pelvic radiation
- Metastatic disease outside of the pelvis
- Active inflammatory bowel disease
- Incapacity to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) |
Primary outcome
Acute clinician-reported gastrointestinal (GI) toxicity.
Time frame: 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.
3 secondary outcomes
Acute clinician-reported genitourinary (GU) toxicity.
Time frame: 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.
Time frame: Up to 6 months after end of treatment at follow up visits
Loco-regional recurrence free survival, disease free survival, and overall survival.
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil K Taunk, MD, MSCTS principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in people with Cervical Cancer and Uterine Cancer, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (215-662-3790, RadOncCRU@PennMedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute clinician-reported gastrointestinal (GI) toxicity. (time frame: Up to 6 months after end of treatment at follow up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.