Gynaecologic CancerPhase 2NCT07415681
GCCC 2578 Randomized Photon vs Proton RT for Newly Diagnosed Gynecologic Primaries
A Phase 2 study testing Volume Modulated Arc Therapy (VMAT) and Intensity Modulated Proton Therapy (IMPT) in people with Gynaecologic Cancer and Cervical Cancer, run by University of Maryland, Baltimore at 5 sites in United States.
Trial summary
The purpose of study is to compare the side effects of two different forms of radiation for endometrial and cervical cancer. If you decide to enroll in this study, you will be randomized to one of two treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynaecologic Cancer, Cervical Cancer, Radiation Therapy
- What is being tested?
- Volume Modulated Arc Therapy (VMAT) and Intensity Modulated Proton Therapy (IMPT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Mar 2026to Dec 2033
- 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
- a. Newly diagnosed endometrial cancer after TAH/BSO and nodal sampling, sentinel LN biopsy or pelvic nodal dissection planning to receive sequential chemotherapy and radiation or concurrent chemoradiotherapy or b. cervical cancer planning to receive definitive chemoradiation with HDR brachytherapy boost
- Histologic confirmation of malignancy (primary only)
- ≥ 18 years of age
- ECOG performance status ≤ 2
- Patient must have the ability to understand and the willingness to sign a written informed consent document or when appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf.
- Insurance approval for IMPT
Who cannot join
- Metastatic disease beyond para-aortic lymph nodal region
- Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer.
- FIGO 2014 stage III-IVA cervix cancer planning to receive concurrent pembrolizumab.
- Cervical cancer with inability to receive concurrent chemotherapy.
- Any prior pelvic radiation.
- Treatment with other investigational agents.
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- Carcinosarcoma.
- Creatine clearance <30 mL/m2
- Unable to lie flat during or tolerate radiation.
- Refusal to sign informed consent.
- Any additional active cancer that would interfere with the primary study endpoints
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Caitlin Eggleston, 410-369-7586, caitlineggleston@umm.edu
- Recruiting
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Caitlin Eggleston, BS, 4103287586, caitlineggleston@umm.edu
- Recruiting
Upper Chesapeake Health
Bel Air, Maryland, 21014
Lalicia Roman, 443-643-1877, lalicia.roman@umm.edu
- Recruiting
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Caitlin Eggleston, 410-328-7586, caitlineggleston@umm.edu
- Recruiting
Baltimore Washington Medical Center- Tate Cancer Center
Glen Burnie, Maryland, 21061
Pilar Strycula, 410-553-8110, p.strycula@umm.edu
About this study
Official title: A Phase II, Randomized, Open-Label, Single-Center Study Comparing Intensity Modulated Proton Therapy Versus Volume Modulated Arc Therapy in Patients Receiving Pelvic Nodal Irradiation for Newly Diagnosed Gynecologic Primaries
The purpose of study is to compare the side effects of two different forms of radiation for endometrial and cervical cancer. If you decide to enroll in this study, you will be randomized to one of two treatment groups. This study will compare two standard of care treatments: "Conventional" pHoton radiation versus pRoton radiation.
- Conditions
- Gynaecologic Cancer, Cervical Cancer, Radiation Therapy
- Being tested
- Volume Modulated Arc Therapy (VMAT), Intensity Modulated Proton Therapy (IMPT)
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume Modulated Arc Therapy (VMAT)Radiation
Also called Arm 1
VMAT RT- 45-50.4 Gy in 1.8-2 Gy fractions
All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.
Intensity Modulated Proton Therapy (IMPT)Radiation
Also called Arm 2
IMPT- 45-50.4 Gy in 1.8-2 Gy fractions
All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy.
| Study group | Role | What they receive |
|---|---|---|
| Photon Radiation | Active comparator | Photon Radiation Therapy (Volume Modulated Arc Therapy (VMAT)) Receives: Radiation: Volume Modulated Arc Therapy (VMAT) |
| Proton Radiation | Active comparator | Proton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT)) Receives: Radiation: Intensity Modulated Proton Therapy (IMPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0
To compare patient reported acute gastrointestinal toxicity specifically grade 2 or higher (CTCAE) diarrhea events between IMPT and VMAT for patients receiving pelvic nodal irradiation for newly diagnosed cervical and endometrial cancer.
Measured: 2-years following completion of treatment
Secondary outcomes (6)
Incidence of grade 4 (via CTCAE) lymphopenia during radiation between IMPT and VMAT
To compare the incidence of grade 4 lymphopenia during radiation between IMPT and VMAT for patients receiving pelvic nodal irradiation for newly diagnosed cervical and endometrial cancer.
Measured: 2-year following completion of treatment
Number of patients with decreased lymphocyte values at first follow-up visit post radiation
To compare lymphocyte nadir at first follow-up visit after completion of radiation.
Measured: 3 months post completion of RT
Number of patients with physician reported GI toxicities assessed by CTCAE v5
To compare physician reported GI outcomes between arms.
Measured: 2 years post radiation treatment
Rates of treatment completion within scheduled time frame
To compare rates of treatment completion within scheduled time frame between arms.
Measured: 2 years post treament
GI, GU and hematologic grade 2 or higher late toxicity events (via CTCAE)
To compare GI, GU and hematologic grade 2 or higher late toxicity events between arms.
Measured: 2 years post treatment completion
Compare 2-year overall survival, local failure and distant failure
To compare 2-year overall survival, local failure and distant failure between arms.
Measured: 2 years post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start25 Mar 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecologic CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Nichols, University of Maryland, Baltimore
- Investigators
- Elizabeth Nichols, MD, Principal investigator, University of Maryland Medical Center/Maryland Proton Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415681
- Sponsor's protocol ID
- HP-00116109
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Open-Label, Single-Center Study Comparing Intensity Modulated Proton Therapy Versus Volume Modulated Arc Therapy in Patients Receiving Pelvic Nodal Irradiation for Newly Diagnosed Gynecologic Primaries
- ClinicalTrials.gov ID
- NCT07415681
- Acronym / sponsor ID
- HP-00116109
- Conditions
- Gynaecologic Cancer, Cervical Cancer, Radiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 17 Feb 2026 (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.
The purpose of study is to compare the side effects of two different forms of radiation for endometrial and cervical cancer. If you decide to enroll in this study, you will be randomized to one of two treatment groups. This study will compare two standard of care treatments: "Conventional" pHoton radiation versus pRoton radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photon Radiation | Active comparator | Radiation: Volume Modulated Arc Therapy (VMAT)Photon Radiation Therapy (Volume Modulated Arc Therapy (VMAT)) |
| Proton Radiation | Active comparator | Radiation: Intensity Modulated Proton Therapy (IMPT)Proton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT)) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- a. Newly diagnosed endometrial cancer after TAH/BSO and nodal sampling, sentinel LN biopsy or pelvic nodal dissection planning to receive sequential chemotherapy and radiation or concurrent chemoradiotherapy or b. cervical cancer planning to receive definitive chemoradiation with HDR brachytherapy boost
- Histologic confirmation of malignancy (primary only)
- ≥ 18 years of age
- ECOG performance status ≤ 2
- Patient must have the ability to understand and the willingness to sign a written informed consent document or when appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf.
Key exclusion criteria (11 listed)
- Metastatic disease beyond para-aortic lymph nodal region
- Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer.
- FIGO 2014 stage III-IVA cervix cancer planning to receive concurrent pembrolizumab.
- Cervical cancer with inability to receive concurrent chemotherapy.
- Any prior pelvic radiation.
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 |
|---|---|---|
| Volume Modulated Arc Therapy (VMAT)Also: Arm 1VMAT RT- 45-50.4 Gy in 1.8-2 Gy fractions All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy. | Radiation | Photon Radiation |
| Intensity Modulated Proton Therapy (IMPT)Also: Arm 2IMPT- 45-50.4 Gy in 1.8-2 Gy fractions All patients will receive concurrent cisplatin 40 mg/m2 on a weekly basis during EBRT in accordance with standard of care. No chemotherapy will be utilized during HDR brachytherapy. | Radiation | Proton Radiation |
Primary outcome
Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0
Time frame: 2-years following completion of treatment
To compare patient reported acute gastrointestinal toxicity specifically grade 2 or higher (CTCAE) diarrhea events between IMPT and VMAT for patients receiving pelvic nodal irradiation for newly diagnosed cervical and endometrial cancer.
6 secondary outcomes
Incidence of grade 4 (via CTCAE) lymphopenia during radiation between IMPT and VMAT
Time frame: 2-year following completion of treatment
Number of patients with decreased lymphocyte values at first follow-up visit post radiation
Time frame: 3 months post completion of RT
Number of patients with physician reported GI toxicities assessed by CTCAE v5
Time frame: 2 years post radiation treatment
Rates of treatment completion within scheduled time frame
Time frame: 2 years post treament
GI, GU and hematologic grade 2 or higher late toxicity events (via CTCAE)
Time frame: 2 years post treatment completion
Compare 2-year overall survival, local failure and distant failure
Time frame: 2 years post treatment completion
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Elizabeth Nichols, MD principal investigator
University of Maryland Medical Center/Maryland Proton Treatment Center
5 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 Volume Modulated Arc Therapy (VMAT) and Intensity Modulated Proton Therapy (IMPT) in people with Gynaecologic Cancer and Cervical Cancer, run by University of Maryland, Baltimore at 5 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 6 inclusion and 11 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Elizabeth Nichols, MD (410-328-6080, enichols1@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0 (time frame: 2-years following completion of treatment). 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 10 Aug 2026.